The Medical Letter - 2023
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January 9, 2023 (Issue 1667)
- Drugs for Chronic Insomnia Cognitive behavioral therapy for insomnia (CBT-I) is recommended for initial treatment of chronic insomnia. CBT-I includes stimulus control, sleep education and hygiene, sleep restriction, relaxation...
- Expanded Table: Some Oral Drugs for Chronic Insomnia (online only) View the Expanded Table: Some Oral Drugs for Chronic Insomnia
- Teplizumab (Tzield) to Delay Onset of Type 1 Diabetes Teplizumab-mzwv (Tzield – Provention Bio), an anti-CD3 monoclonal antibody, has been approved by the FDA to delay the onset of stage 3 type 1 diabetes in patients ≥8 years old who have stage 2 type...
- COVID-19 Update: Tocilizumab (Actemra) FDA-Approved for Treatment of COVID-19 (online only) The interleukin-6 (IL-6) receptor antagonist tocilizumab (Actemra – Genentech) has been approved by the FDA for IV treatment of COVID-19 in hospitalized adults who are receiving a systemic corticosteroid...
January 23, 2023 (Issue 1668)
- Hemgenix - A Gene Therapy for Hemophilia B Etranacogene dezaparvovec-drlb (Hemgenix – CSL Behring), an adeno-associated virus vector-based gene therapy, has been approved by the FDA for treatment of hemophilia B in adults who currently receive...
- Topical Roflumilast (Zoryve) for Plaque Psoriasis The FDA has approved a 0.3% cream formulation of the phosphodiesterase-4 (PDE4) inhibitor roflumilast (Zoryve – Arcutis) for topical treatment of plaque psoriasis in patients ≥12 years old. Roflumilast...
- Olopatadine/Mometasone (Ryaltris) for Allergic Rhinitis The FDA has approved Ryaltris (Hikma), a fixed-dose combination nasal spray containing the H1-antihistamine olopatadine hydrochloride (Patanase, and generics) and the corticosteroid mometasone furoate...
- In Brief: Furoscix - A Subcutaneous Furosemide Infusor for Heart Failure The FDA has approved Furoscix (scPharmaceuticals), a subcutaneous formulation of the loop diuretic furosemide administered via a single-use, on-body infusor, for treatment of congestion due to...
- In Brief: Finerenone (Kerendia) for Diabetic Kidney Disease Recently published guidelines from the American Diabetes Association (ADA) and the Kidney Disease: Improving Global Outcomes (KDIGO) Diabetes Work Group recommend addition of the oral...
- Adagrasib (Krazati) for NSCLC (online only) Adagrasib (Krazati – Mirati Therapeutics), a RAS GTPase family inhibitor, has received accelerated approval from the FDA for oral treatment of KRAS G12C-mutated locally advanced or metastatic...
- Opdualag for Metastatic Melanoma (online only) Opdualag (BMS), a fixed-dose combination of two immune checkpoint inhibitors — nivolumab (Opdivo), a programmed death receptor-1 (PD-1) inhibitor, and relatlimab-rmbw, a lymphocyte-activation...
February 6, 2023 (Issue 1669)
- Lecanemab (Leqembi) for Alzheimer's Disease Lecanemab-irmb (Leqembi – Biogen/Eisai), an IV amyloid beta-directed monoclonal antibody, has received accelerated approval from the FDA for treatment of Alzheimer's disease. The label states that...
- Dupilumab (Dupixent) for Eosinophilic Esophagitis and Prurigo Nodularis The FDA has approved the subcutaneously injected interleukin (IL)-4 receptor alpha antagonist dupilumab (Dupixent – Sanofi/Regeneron) for treatment of eosinophilic esophagitis (EoE) in patients ≥12...
- Epsolay - A Benzoyl Peroxide Cream for Rosacea Epsolay (Galderma), a 5% benzoyl peroxide cream, has been approved by the FDA for treatment of inflammatory lesions of rosacea in adults. It is the first product containing benzoyl peroxide to be...
- Transdermal Dextroamphetamine (Xelstrym) for ADHD The FDA has approved a dextroamphetamine transdermal patch (Xelstrym – Noven) for once-daily treatment of attention-deficit/hyperactivity disorder (ADHD) in patients ≥6 years old. Xelstrym is the...
- COVID-19 Update: Evusheld Unlikely to Neutralize XBB.1.5 Omicron Variant (online only) The FDA has warned that the investigational long-acting monoclonal antibodies tixagevimab and cilgavimab (Evusheld – AstraZeneca) are unlikely to neutralize the XBB.1.5 Omicron variant of SARS-CoV-2....
- In Brief: A New Indication for Dabrafenib (Tafinlar) and Trametinib (Mekinist) Combination Therapy (online only) The oral kinase inhibitors dabrafenib (Tafinlar – GSK) and trametinib (Mekinist – Novartis) have received accelerated approval by the FDA for use together for a fifth indication: treatment of...
- Table: Inhibitors and Inducers of CYP Enzymes, P-Glycoprotein, and Other Transporters (online only) View the Inhibitors and Inducers of CYP Enzymes, P-Glycoprotein, and Other Transporters tables
- Tremelimumab (Imjudo) for Metastatic NSCLC (online only) The FDA has approved tremelimumab-actl (Imjudo – AstraZeneca), a cytotoxic T-lymphocyte-associated antigen 4 (CTLA-4) blocking antibody, for use in combination with the programmed death-ligand 1 (PD-L1)...
February 20, 2023 (Issue 1670)
- Drugs for Hypothyroidism Primary hypothyroidism is usually the result of Hashimoto's (autoimmune) thyroiditis, thyroidectomy, or radioactive iodine therapy. Treatment of hypothyroidism with replacement doses of thyroid hormone is...
- Deucravacitinib (Sotyktu) for Plaque Psoriasis The FDA has approved deucravacitinib (Sotyktu – BMS), an oral tyrosine kinase 2 (TYK2) inhibitor, for once-daily treatment of moderate to severe plaque psoriasis in adults who are candidates for...
- In Brief: Expanded Access to Mifepristone First approved in 2000 for termination of pregnancies of ≤49 days' gestation, the indication for the oral antiprogestin mifepristone (Mifeprex, and generics) was expanded in 2016 to include pregnancies...
- In Brief: Semaglutide (Wegovy) for Weight Loss in Children The injectable glucagon-like peptide-1 (GLP-1) receptor agonist semaglutide (Wegovy), which was approved by the FDA in 2021 for chronic weight management in adults, has now been approved for chronic weight...
- In Brief: Zanubrutinib (Brukinsa) for CLL or SLL (online only) The Bruton's tyrosine kinase (BTK) inhibitor zanubrutinib (Brukinsa), which was previously approved by the FDA for treatment of mantle cell lymphoma, Waldenström's macroglobulinemia, and relapsed or...
- Pirtobrutinib (Jaypirca): A Fourth Bruton's Tyrosine Kinase Inhibitor for Mantle Cell Lymphoma (online only) The Bruton's tyrosine kinase (BTK) inhibitor pirtobrutinib (Jaypirca – Lilly) has received accelerated approval from the FDA for treatment of relapsed or refractory mantle cell lymphoma (MCL) in adults...
- In Brief: A Second Indication for Tucatinib (Tukysa) (online only) The oral kinase inhibitor tucatinib (Tukysa – Seagen) has received accelerated approval from the FDA for use in combination with trastuzumab (Herceptin) for treatment of adults with RAS wild-type...
March 6, 2023 (Issue 1671)
- Antiviral Drugs for COVID-19 in Vaccinated Outpatients Three products are currently available in the US for treatment of high-risk,1 nonhospitalized adults with mild to moderate COVID-19: oral ritonavir-boosted nirmatrelvir (Paxlovid), IV remdesivir (Veklury),...
- Live Fecal Microbiota (Rebyota) for Prevention of CDI Recurrence The FDA has approved Rebyota (Ferring), a rectally-administered, live fecal microbiota suspension, for prevention of additional recurrences of Clostridioides difficile infection (CDI) following antibiotic...
- Ublituximab (Briumvi) for Relapsing Multiple Sclerosis The FDA has approved the recombinant chimeric anti-CD20 antibody ublituximab-xiiy (Briumvi – TG Therapeutics) for IV treatment of adults with relapsing forms of multiple sclerosis (MS),...
- Elacestrant (Orserdu) for Advanced or Metastatic Breast Cancer The FDA has approved elacestrant (Orserdu – Stemline), an oral estrogen receptor antagonist, for treatment of estrogen receptor (ER)-positive, human epidermal growth factor receptor 2...
- In Brief: Adstiladrin – A Gene Therapy for Bladder Cancer (online only) Nadofaragene firadenovec-vncg (Adstiladrin – Ferring), an adenoviral vector-based gene therapy, has been approved by the FDA for treatment of adults with high-risk Bacillus Calmette-Guérin...
- Mosunetuzumab (Lunsumio) for Follicular Lymphoma (online only) Mosunetuzumab-axgb (Lunsumio – Genentech), a bispecific CD20-directed CD3 T-cell engager, has received accelerated approval from the FDA for treatment of relapsed or refractory follicular lymphoma in...
- In Brief: A New Breast Cancer Indication for Sacituzumab Govitecan (Trodelvy) (online only) Sacituzumab govitecan-hziy (Trodelvy – Gilead) has been approved for treatment of unresectable locally advanced or metastatic hormone receptor (HR)-positive, human epidermal growth factor receptor...
March 20, 2023 (Issue 1672)
- Drugs for Overactive Bladder In overactive bladder, involuntary bladder contractions due to detrusor overactivity result in urinary urgency, frequency, nocturia, and incontinence. The prevalence of the disorder increases with...
- A Dexamethasone Ophthalmic Insert (Dextenza) for Allergic Conjunctivitis The FDA has approved Dextenza (Ocular Therapeutix), a dexamethasone ophthalmic insert, for treatment of ocular itching associated with allergic conjunctivitis. Dextenza was approved earlier for treatment of...
- Terlipressin (Terlivaz) for Hepatorenal Syndrome The FDA has approved the intravenously administered synthetic vasopressin analog terlipressin (Terlivaz – Mallinckrodt) to improve kidney function in adults with hepatorenal syndrome (HRS) and a rapid...
- In Brief: Off-Label Amitriptyline for Insomnia In our article on Drugs for Chronic Insomnia, we said there is little evidence that antidepressants such as trazodone, mirtazapine, or amitriptyline are effective in treating insomnia not associated with...
April 3, 2023 (Issue 1673)
- Pegcetacoplan (Syfovre) for Geographic Atrophy in Age-Related Macular Degeneration The FDA has approved the complement C3 inhibitor pegcetacoplan (Syfovre – Apellis) for treatment of geographic atrophy (GA) secondary to age-related macular degeneration (AMD). Given as a series...
- Three Drugs for Atopic Dermatitis (Adbry, Cibinqo, and Rinvoq) The subcutaneously injected interleukin-13 (IL-13) antagonist tralokinumab-ldrm (Adbry – Leo) and the oral Janus kinase (JAK) inhibitors abrocitinib (Cibinqo – Pfizer) and upadacitinib (Rinvoq –...
- In Brief: Rezvoglar - Another Insulin Glargine Product Interchangeable with Lantus Insulin glargine-aglr (Rezvoglar – Lilly), which was approved by the FDA as a biosimilar to the reference product Lantus in 2021 and received interchangeability status with Lantus in 2022, will become...
- Atezolizumab (Tecentriq) for Alveolar Soft Part Sarcoma (online only) Atezolizumab (Tecentriq – Genentech), an immune checkpoint inhibitor, has been approved by the FDA for treatment of unresectable or metastatic alveolar soft part sarcoma (ASPS) in patients ≥2 years old....
- Olutasidenib (Rezlidhia) for Acute Myeloid Leukemia (online only) Olutasidenib (Rezlidhia – Rigel), an oral isocitrate dehydrogenase-1 (IDH1) inhibitor, has been approved by the FDA for treatment of relapsed or refractory acute myeloid leukemia (AML) in adults with a...
- In Brief: Fam-trastuzumab deruxtecan (Enhertu) for Breast Cancer (online only) Fam-trastuzumab deruxtecan-nxki (Enhertu – Daiichi Sankyo/AstraZeneca), which received accelerated approval by the FDA in 2019 for treatment of HER2-positive breast cancer based on its rate and duration of...
- In Brief: A New Indication for Abemaciclib (Verzenio) (online only) The oral cyclin-dependent kinase (CDK) 4/6 inhibitor abemaciclib (Verzenio – Lilly) has been approved by the FDA for use in combination with endocrine therapy (tamoxifen or an aromatase inhibitor) for...
- Dostarlimab (Jemperli) for Endometrial Cancer (online only) The FDA has granted regular approval to dostarlimabgxly (Jemperli – GSK), an immune checkpoint inhibitor, for treatment of adults with mismatch repair deficient (dMMR) recurrent or advanced...
April 17, 2023 (Issue 1674)
- Treatment of Common Respiratory Tract Infections Most respiratory tract infections are caused by viruses. Bacterial respiratory tract infections are usually treated empirically with antibiotic therapy that targets the most probable causative...
- In Brief: Cardiovascular Outcomes with Bempedoic Acid (Nexletol) Since our initial review of the oral lipid-lowering adenosine triphosphate-citrate lyase (ACL) inhibitor bempedoic acid (Nexletol – Esperion) in 2020, cardiovascular outcomes data in...
- COVID-19 Update: Pfizer Bivalent Vaccine Booster Dose for Children 6 Months to 4 Years Old The FDA has expanded its Emergency Use Authorization (EUA) for the COVID-19 vaccine manufactured by Pfizer/BioNTech (Comirnaty) to permit use of the bivalent formulation (containing mRNA from the original...
- Capmatinib (Tabrecta) for NSCLC (online only) The FDA has granted regular approval to the oral kinase inhibitor capmatinib (Tabrecta – Novartis) for treatment of metastatic non-small cell lung cancer (NSCLC) in adults whose tumors have a mutation...
- Cemiplimab (Libtayo) for NSCLC (online only) The FDA has approved cemiplimab-rwlc (Libtayo – Regeneron), an immune checkpoint inhibitor, for use in combination with platinum-based chemotherapy for first-line treatment of locally advanced or...
- Futibatinib (Lytgobi) for Cholangiocarcinoma (online only) The oral kinase inhibitor futibatinib (Lytgobi – Taiho) has received accelerated approval from the FDA for treatment of adults with previously treated, unresectable, locally advanced or...
- In Brief: A New Indication for Pemigatinib (Pemazyre) (online only) The oral kinase inhibitor pemigatinib (Pemazyre – Incyte) has been approved by the FDA for treatment of adults with relapsed or refractory myeloid/lymphoid neoplasms (MLNs) with fibroblast growth factor...
- In Brief: Retifanlimab (Zynyz) for Merkel Cell Carcinoma (online only) Retifanlimab-dlwr (Zynyz – Incyte), a programmed death receptor-1 (PD-1) blocking antibody, has received accelerated approval from the FDA for treatment of metastatic or recurrent locally advanced Merkel...
- In Brief: Dabrafenib (Tafinlar) and Trametinib (Mekinist) for Glioma (online only) The oral kinase inhibitors dabrafenib (Tafinlar – GSK) and trametinib (Mekinist – Novartis) have been approved by the FDA for use together for a sixth indication: treatment of low-grade glioma...
- In Brief: Olaparib (Lynparza) for High-Risk Early Breast Cancer (online only) The oral poly(ADP-ribose) polymerase (PARP) inhibitor olaparib (Lynparza – AstraZeneca) has been approved by the FDA for adjuvant treatment of adults with deleterious or suspected deleterious...
May 1, 2023 (Issue 1675)
- Vibrant – An Oral Vibrating Capsule for Chronic Idiopathic Constipation The Vibrant orally administered vibrating capsule (Vibrant Gastro), an FDA-cleared medical device, is now available by prescription for treatment of adults with chronic idiopathic constipation (CIC) who...
- Altuviiio – A Longer-Acting Factor VIII Product for Hemophilia A The FDA has approved Altuviiio (Sanofi), a von Willebrand Factor (VWF)-independent, recombinant factor VIII concentrate, for routine prophylaxis, on-demand treatment to control bleeding episodes,...
- Lenacapavir (Sunlenca) for Multidrug-Resistant HIV The FDA has approved oral and injectable formulations of the HIV-1 capsid inhibitor lenacapavir (Sunlenca – Gilead) for use with other antiretroviral drugs to treat multidrug-resistant HIV-1...
- Cyclosporine Ophthalmic Emulsion (Verkazia) for Vernal Keratoconjunctivitis The FDA has approved Verkazia (Santen), a 0.1% ophthalmic emulsion formulation of the calcineurin inhibitor cyclosporine, for treatment of vernal keratoconjunctivitis (VKC). Verkazia is the first product to...
- In Brief: Over-the-Counter Narcan Nasal Spray The FDA has approved the over-the-counter (OTC) sale of Narcan (Emergent), a nasal spray that delivers 4 mg of the opioid antagonist naloxone. Narcan nasal spray has been available by prescription since...
- Vaccination Recommendations for Bivalent mRNA COVID-19 Vaccines (online only) View the Vaccination Recommendations for Bivalent mRNA COVID-19 Vaccines
- Dosing Recommendations for Novavax and Johnson & Johnson COVID-19 Vaccines (online only) View the Dosing Recommendations for Novavax and Johnson & Johnson COVID-19 Vaccines
May 15, 2023 (Issue 1676)
- Choice of Contraceptives Intrauterine devices (IUDs) and the etonogestrel implant are the most effective reversible contraceptive methods available. Hormonal oral contraceptives, patches, rings, and injectables are also effective...
May 29, 2023 (Issue 1677)
- Live Fecal Microbiota Oral Capsules (Vowst) for Prevention of CDI Recurrence The FDA has approved Vowst (Seres Therapeutics/Nestle HealthScience), an oral capsule containing live fecal microbiota spores, for prevention of additional recurrences of Clostridioides difficile infection...
- Eflapegrastim (Rolvedon) for Prevention of Chemotherapy-Induced Febrile Neutropenia Eflapegrastim-xnst ((Rolvedon) [Spectrum]; previously called Rolontis), a granulocyte colony-stimulating factor (G-CSF) conjugated to an Fc fragment of human IgG4, has been approved by the FDA to...
- Cariprazine (Vraylar) for Adjunctive Treatment of Depression The FDA has approved the second-generation antipsychotic drug cariprazine (Vraylar — Abbvie) for adjunctive treatment of major depressive disorder (MDD) in adults. Cariprazine was previously approved for...
- COVID-19 Update: An EUA for Vilobelimab (Gohibic) for COVID-19 The investigational anti-complement component 5a (C5a) antibody vilobelimab (Gohibic – InflaRx) has been granted an FDA Emergency Use Authorization (EUA) for IV treatment of hospitalized adults with...
- COVID-19 Update: Metformin to Prevent Long Covid? Results from a double-blind trial suggest that off-label use of the oral antihyperglycemic drug metformin in patients with COVID-19 may decrease the risk of post-acute sequelae of SARS-CoV-2...
- Polatuzumab vedotin (Polivy) for Lymphoma (online only) Polatuzumab vedotin-piiq (Polivy – Genentech), a CD79b-directed antibody and microtubule inhibitor conjugate, has been approved by the FDA for use in combination with rituximab,...
- Enfortumab Vedotin (Padcev) for Urothelial Cancer (online only) Enfortumab vedotin-ejfv (Padcev – Astellas), a nectin-4-directed antibody and microtubule inhibitor conjugate, has received accelerated approval from the FDA for use with the immune checkpoint inhibitor...
- Omidubicel (Omisirge) for Neutrophil Recovery Following Myeloablative Conditioning Therapy (online only) The FDA has approved omidubicel-onlv (Omisirge – Gamida Cell), a nicotinamide-modified, allogeneic hematopoietic progenitor cell therapy derived from cord blood, to reduce the time to neutrophil...
June 12, 2023 (Issue 1678)
- Drugs for Migraine An oral nonopioid analgesic is often sufficient for acute treatment of mild to moderate migraine pain without severe nausea or vomiting. A triptan is the drug of choice for treatment of moderate to...
- Comparison Table: Triptans for Migraine (online only) View the Comparison Table: Triptans for Migraine
- Comparison Table: Some Drugs for Migraine Prevention in Adults (online only) View the Comparison Table: Some Drugs for Migraine Prevention in Adults
- Epcoritamab (Epkinly) for Diffuse Large B-Cell Lymphoma (DLBCL) (online only) Epcoritamab-bysp (Epkinly – Genmab), a bispecific CD20-directed CD3 T-cell engager, has received accelerated approval from the FDA for subcutaneous treatment of relapsed or refractory diffuse large B-cell...
- Sotorasib (Lumakras) for NSCLC (online only) Sotorasib (Lumakras — Amgen), an oral KRAS inhibitor, has received accelerated approval by the FDA for treatment of KRAS G12C-mutated locally advanced or metastatic non-small cell lung cancer (NSCLC) in...
- In Brief: Brexucabtagene autoleucel (Tecartus) for Acute Lymphoblastic Leukemia (online only) Brexucabtagene autoleucel (Tecartus – Kite) has been approved by the FDA for treatment of adults with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL). It was previously approved...
- Asciminib (Scemblix) for Chronic Myeloid Leukemia (online only) Asciminib (Scemblix – Novartis), an oral kinase inhibitor, has been approved by the FDA for treatment of adults with Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML) in chronic phase...
June 26, 2023 (Issue 1679)
- Fezolinetant (Veozah) for Menopausal Vasomotor Symptoms Fezolinetant (Veozah – Astellas), a first-in-class neurokinin 3 (NK3) receptor antagonist, has been approved by the FDA for treatment of moderate to severe vasomotor symptoms (VMS) due to menopause. It is...
- Brexpiprazole (Rexulti) for Agitation in Alzheimer's Dementia The FDA has approved the oral second-generation antipsychotic drug brexpiprazole (Rexulti – Otsuka/Lundbeck) for once-daily treatment of agitation associated with dementia due to Alzheimer's disease...
- In Brief: Expanded Heart Failure Indication for Dapagliflozin (Farxiga) The sodium-glucose cotransporter 2 (SGLT2) inhibitor dapagliflozin (Farxiga – AstraZeneca) was approved by the FDA in 2020 to reduce the risk of cardiovascular death and hospitalization for heart failure...
- In Brief: Alternatives to Mifepristone for Medication Abortion The possibility that use of mifepristone (Mifeprex, and generics) may be restricted has led to questions about alternatives for medication abortion.
- In Brief: OTC Ivermectin for Head Lice Topical ivermectin lotion 0.5% (Sklice, and generics), which has been available by prescription since 2012, is now FDA-approved for sale over the counter (OTC) for treatment of head lice in patients ≥6...
- In Brief: Lisocabtagene Maraleucel (Breyanzi) for Large B-Cell Lymphoma (online only) The FDA has approved lisocabtagene maraleucel (Breyanzi – BMS) for treatment of adults with large B-cell lymphoma (LBCL), including diffuse large B-cell lymphoma (DLBCL) not otherwise...
- In Brief: A New Prostate Cancer Indication for Olaparib (Lynparza) (online only) The oral poly(ADP-ribose) polymerase (PARP) inhibitor olaparib (Lynparza – AstraZeneca) has now been approved by the FDA for use in combination with abiraterone (Zytiga, and others) and either prednisone...
- In Brief: A New Prostate Cancer Indication for Darolutamide (Nubeqa) (online only) The androgen receptor inhibitor darolutamide (Nubeqa – Bayer) has been approved by the FDA for use in combination with docetaxel for treatment of metastatic hormone-sensitive prostate cancer (mHSPC). The...
July 10, 2023 (Issue 1680)
- Drugs for Inflammatory Bowel Disease Ulcerative colitis (UC) and Crohn's disease (CD), referred to collectively as inflammatory bowel disease (IBD), are chronic immune-mediated inflammatory conditions. Guidelines for treatment of UC and...
- Table: Safety of Drugs for IBD in Pregnancy (online only) View the Table: Safety of Drugs for IBD in Pregnancy
- Table: Some Drug Interactions with Drugs for IBD (online only) View the Table: Some Drug Interactions with Drugs for IBD
- Expanded Table: Some Drugs for Inflammatory Bowel Disease (online only) View the Table: Some Drugs for Inflammatory Bowel Disease
- Two Drugs for RET-Altered Cancers (Retevmo and Gavreto) (online only) The oral kinase inhibitors selpercatinib (Retevmo – Lilly) and pralsetinib (Gavreto – Blueprint Medicines/Genentech) have been approved by the FDA for treatment of advanced or metastatic RET-mutant or...
July 24, 2023 (Issue 1681)
- Tofersen (Qalsody) for ALS Tofersen (Qalsody – Biogen), an intrathecally administered antisense oligonucleotide, has received accelerated approval from the FDA for treatment of amyotrophic lateral sclerosis (ALS) in adults who have...
- Sotagliflozin (Inpefa) for Heart Failure The FDA has approved sotagliflozin (Inpefa – Lexicon), an oral sodium-glucose cotransporter 1 and 2 (SGLT1/2) inhibitor, to reduce the risk of hospitalization for heart failure (HF), urgent HF visits, and...
- Zavegepant (Zavzpret) for Acute Treatment of Migraine The FDA has approved zavegepant nasal spray (Zavzpret – Pfizer) for acute treatment of migraine with or without aura in adults. Zavzpret is the first nasal spray formulation of a calcitonin...
- Inspire for Obstructive Sleep Apnea The FDA recently expanded the eligibility criteria (see Table 1) for treatment with the surgically implanted hypoglossal nerve stimulation system (Inspire Upper Airway Stimulation – Inspire...
- Relugolix (Orgovyx) for Advanced Prostate Cancer (online only) The oral gonadotropin-releasing hormone (GnRH) receptor antagonist relugolix (Orgovyx – Myovant Sciences/Pfizer) has been approved by the FDA for treatment of advanced prostate cancer in adults. It is the...
August 7, 2023 (Issue 1682)
- Drugs for Anxiety Disorders Anxiety disorders (generalized anxiety disorder, panic disorder, social anxiety disorder, and various phobias) are the most common form of psychiatric illness. They can be treated effectively with...
- Glofitamab (Columvi) for Diffuse Large B-Cell Lymphoma (online only) Glofitamab-gxbm (Columvi – Genentech), a bispecific CD20-directed CD3 T-cell engager, has received accelerated approval from the FDA for IV treatment of relapsed or refractory diffuse large B-cell...
- Osimertinib (Tagrisso) for Adjuvant Treatment of NSCLC (online only) The FDA has approved osimertinib (Tagrisso – AstraZeneca), an oral kinase inhibitor, for adjuvant treatment of non-small cell lung cancer (NSCLC) after tumor resection in adults who have epidermal growth...
- In Brief: Tafasitamab (Monjuvi) for Diffuse Large B-Cell Lymphoma (online only) Tafasitamab-cxix (Monjuvi – Morphosys), a CD19-directed cytolytic antibody, has received accelerated approval from the FDA for use in combination with lenalidomide (Revlimid) for treatment of relapsed...
- Talazoparib (Talzenna) for Prostate Cancer (online only) The oral poly(ADP-ribose) polymerase (PARP) inhibitor talazoparib (Talzenna – Pfizer) has been approved by the FDA for use in combination with the androgen receptor blocker enzalutamide (Xtandi)...
August 21, 2023 (Issue 1683)
- Lecanemab (Leqembi) Granted Full Approval for Early Alzheimer's Disease Lecanemab-irmb (Leqembi – Eisai/Biogen), the IV amyloid-directed monoclonal antibody that received accelerated approval from the FDA in January 2023 for treatment of early Alzheimer's disease, has...
- Bexagliflozin (Brenzavvy) — A Fifth SGLT2 Inhibitor for Type 2 Diabetes Bexagliflozin (Brenzavvy – TheracosBio), a sodium-glucose cotransporter 2 (SGLT2) inhibitor, has been approved by the FDA to improve glycemic control in adults with type 2 diabetes. It is the fifth...
- Once-Weekly or Once-Monthly Subcutaneous Buprenorphine (Brixadi) for Opioid Use Disorder The FDA has approved a subcutaneously injected, extended-release formulation of the mu-opioid receptor partial agonist and kappa-opioid receptor antagonist buprenorphine (Brixadi – Braeburn) for...
- Linaclotide (Linzess) for Functional Constipation The guanylate cyclase-C receptor agonist linaclotide (Linzess – Abbvie/Ironwood) was first approved by the FDA in 2012 for treatment of chronic idiopathic constipation and irritable bowel syndrome...
- Empagliflozin (Jardiance) for Type 2 Diabetes in Children (online only) The sodium-glucose cotransporter 2 (SGLT2) inhibitor empagliflozin has been available for years alone (Jardiance – Boehringer Ingelheim) and in combination with metformin (Synjardy) to improve glycemic...
- In Brief: A New Endometrial Cancer Indication for Dostarlimab (Jemperli) (online only) The immune checkpoint inhibitor dostarlimab-gxly (Jemperli – GSK) has been approved by the FDA for use in combination with carboplatin and paclitaxel for treatment of adults with mismatch repair...
September 4, 2023 (Issue 1684)
- Drugs for Opioid Use Disorder Opioid use disorder is a chronic, relapsing disease with physical and psychiatric components. It is associated with economic hardship, social isolation, incarceration, increased rates of blood-borne...
- Comparison Table: Some Drugs for Maintenance Treatment of Opioid Use Disorder (online only) View Comparison Table: Some Drugs for Maintenance Treatment of Opioid Use Disorder
- Niraparib/Abiraterone Acetate (Akeega) for Prostate Cancer (online only) Akeega (Janssen), a fixed-dose combination of the oral poly(ADP-ribose) polymerase (PARP) inhibitor niraparib (Zejula) and the antiandrogen abiraterone acetate (Zytiga, and others), has been approved by the...
- In Brief: Melphalan (Hepzato) for Uveal Melanoma (online only) The alkylating agent melphalan (Hepzato – Delcath) has been approved by the FDA for treatment of uveal melanoma in adults with unresectable hepatic metastases that affects...
- Talquetamab (Talvey) for Multiple Myeloma (online only) Talquetamab-tgvs (Talvey – Janssen), a bispecific GPRC5D-directed T-cell engager, has been granted accelerated approval by the FDA for treatment of relapsed or refractory multiple myeloma in adults who...
September 18, 2023 (Issue 1685)
- Nirsevimab (Beyfortus) for Prevention of Severe RSV Disease in Young Children The FDA has approved nirsevimab-alip (Beyfortus – AstraZeneca/Sanofi), a long-acting monoclonal antibody, for the prevention of respiratory syncytial virus (RSV) lower respiratory tract disease...
- Suflave — A Low-Volume Colonoscopy Preparation The FDA has approved Suflave (Sebela/Braintree), a low-volume polyethylene glycol (PEG)- and sulfate-based product for cleansing of the colon prior to colonoscopy in adults. Other oral...
- Opill — An OTC Oral Contraceptive The FDA has approved Opill (Perrigo), a progestin-only oral contraceptive that contains norgestrel, for sale over the counter (OTC). Opill is the first oral contraceptive to be approved in the US for sale...
- Elranatamab (Elrexfio) for Multiple Myeloma (online only) Elranatamab-bcmm (Elrexfio – Pfizer), a bispecific B-cell maturation antigen (BCMA)-directed CD3 T-cell engager, has been granted accelerated approval by the FDA for treatment of relapsed or refractory...
October 2, 2023 (Issue 1686)
- Two Vaccines (Arexvy and Abrysvo) for Prevention of RSV Disease Two recombinant vaccines, Arexvy (GSK) and Abrysvo (Pfizer), have been approved by the FDA for prevention of lower respiratory tract disease (LRTD) caused by respiratory syncytial virus (RSV) in...
- Lodoco: Low-Dose Colchicine for Cardiovascular Event Prevention Colchicine (Colcrys, and others), which has been available in the US for decades for prophylaxis and treatment of gout flares and other indications in oral formulations that contain 0.6 mg of the drug, has...
- Valoctocogene Roxaparvovec (Roctavian) – A Gene Therapy for Severe Hemophilia A Valoctocogene roxaparvovec-rvox (Roctavian – Biomarin), an adeno-associated virus (AAV) vector-based gene therapy, has been approved by the FDA for one-time treatment of severe hemophilia A in adults...
- Delandistrogene Moxeparvovec (Elevidys) for Duchenne Muscular Dystrophy Delandistrogene moxeparvovec-rokl (Elevidys – Sarepta), an adeno-associated virus (AAV) vector-based gene therapy, has received accelerated approval from the FDA for treatment of ambulatory children 4-5...
- Addendum: Gabapentinoids and Renal Impairment A nephrologist and longtime reader of The Medical Letter wrote us to say that our recent article entitled Drugs for Anxiety Disorders should have said more about the need for dosage adjustment of gabapentin...
- Addendum: Over-the-Counter Narcan Nasal Spray Since the publication of our articles entitled Drugs for Opioid Use Disorder and In Brief: Over-the-Counter Narcan Nasal Spray earlier this year, Narcan (Emergent), a nasal spray that delivers 4 mg of the...
October 16, 2023 (Issue 1687)
- Influenza Vaccine for 2023-2024 Superseded by The Medical Letter "Influenza Vaccine for 2024-2025" - Issue 1711, September 16, 2024
Annual vaccination in the US against influenza A and B viruses is recommended for everyone ≥6 months old without a contraindication. Influenza vaccines that are available in the US for the 2023-2024... - Nalmefene Nasal Spray (Opvee) for Reversal of Opioid Overdose The FDA has approved an intranasal formulation of the opioid antagonist nalmefene (Opvee – Indivior) for emergency treatment of known or suspected opioid overdose in persons ≥12 years old. Nalmefene,...
- COVID-19 Update: New Pfizer and Moderna Vaccine Formulations for 2023-2024 Superseded by The Medical Letter "COVID-19 Update: New Pfizer and Moderna Vaccine Formulations for 2024-2025" - Issue 1711, September 16, 2024
New 2023-2024 formulations of the mRNA COVID-19 vaccines manufactured by Pfizer/BioNTech (Comirnaty) and... - Quizartinib (Vanflyta) for Acute Myeloid Leukemia (online only) The FDA has approved the oral kinase inhibitor quizartinib (Vanflyta – Daiichi Sankyo) for use in combination with standard cytarabine and anthracycline induction and cytarabine consolidation, and as...
- Vaccination Recommendations for Updated 2023-2024 COVID-19 Vaccines (online only) View the Vaccination Recommendations for Updated 2023-2024 COVID-19 Vaccines
October 30, 2023 (Issue 1688)
- Drugs for Gout Drugs for gout are used to reduce the pain and inflammation of acute flares, decrease the frequency of exacerbations, and lower serum urate levels to prevent recurrent flares, development of tophi,...
- AD-Detect — A Blood Test for Alzheimer's Disease AD-Detect (Quest), a blood test to evaluate Alzheimer's disease risk, is being marketed directly to consumers. It has not been cleared or approved by the FDA (laboratory-developed tests like this one...
- Comparison Table: Some Drugs for Gout (online only) View the Comparison Table: Some Drugs for Gout
November 13, 2023 (Issue 1689)
- Antiviral Drugs for Influenza for 2023-2024 Influenza is generally a self-limited illness, but pneumonia, respiratory failure, and death can occur, especially in patients at increased risk for influenza complications (see Table 1). Antiviral...
- COVID-19 Update: New Novavax Vaccine Formulation for 2023-2024 A new 2023-2024 formulation of the adjuvanted protein subunit COVID-19 vaccine manufactured by Novavax that was developed to more closely target currently circulating SARS-CoV-2 variants has been made...
- In Brief: Empagliflozin (Jardiance) for Chronic Kidney Disease The sodium-glucose cotransporter 2 (SGLT2) inhibitor empagliflozin (Jardiance – Boehringer Ingelheim/Lilly) is now FDA-approved to reduce the risk of sustained eGFR decline, end-stage kidney...
- Correction In our article in issue 1687 on the updated 2023-2024 COVID-19 vaccines from Pfizer and Moderna (Med Lett Drugs Ther 2023; 65:161), the doses and formulations of the Pfizer vaccine were incorrect. A revised...
- Comparison Chart: Antiviral Drugs for Influenza for 2023-2024 (online only) View the Comparison Chart: Antiviral Drugs for Influenza for 2023-2024
November 27, 2023 (Issue 1690)
- Ritlecitinib (Litfulo) for Severe Alopecia Areata The FDA has approved ritlecitinib (Litfulo – Pfizer), an oral JAK and TEC kinase family inhibitor, for treatment of severe alopecia areata in patients ≥12 years old. Ritlecitinib is the second oral drug...
- Etrasimod (Velsipity) for Ulcerative Colitis The oral sphingosine 1-phosphate (S1P) receptor modulator etrasimod (Velsipity – Pfizer) has been approved by the FDA for treatment of moderately to severely active ulcerative colitis in adults. It is...
- Sulbactam/Durlobactam (Xacduro) for Acinetobacter Pneumonia The FDA has approved Xacduro (Innoviva), a combination of the beta-lactam antibacterial sulbactam and the beta-lactamase inhibitor durlobactam, for IV treatment of adults with hospital-acquired or...
- Shockwave Therapy for Erectile Dysfunction Low-intensity extracorporeal shockwave therapy similar to that used to fragment kidney stones or gallstones is a new option for treatment of erectile dysfunction that is now being advertised extensively in...
- In Brief: GI Effects of GLP-1 Receptor Agonists Glucagon-like peptide-1 (GLP-1) receptor agonists and the dual glucose-dependent insulinotropic polypeptide (GIP)/GLP-1 receptor agonist tirzepatide (Mounjaro) are widely prescribed for treatment of type 2...
- Addendum In the printed version of our article entitled Antiviral Drugs for Influenza for 2023-2024 in issue 1689 (Med Lett Drugs Ther 2023; 65:177), the clinical studies section should have included a meta-analysis...
December 11, 2023 (Issue 1691)
- Drugs for Depression A selective serotonin reuptake inhibitor (SSRI) is generally used for initial treatment of major depressive disorder (MDD). A serotonin-norepinephrine reuptake inhibitor (SNRI), bupropion (Wellbutrin SR,...
December 25, 2023 (Issue 1692)
- Zuranolone (Zurzuvae) – An Oral Drug for Postpartum Depression The FDA has approved the oral GABAA receptor modulator zuranolone (Zurzuvae – Sage Therapeutics/Biogen) for treatment of postpartum depression (PPD). Zuranolone is the second drug to be approved for this...
- Vonoprazan (Voquezna) for Erosive Esophagitis The FDA has approved vonoprazan (Voquezna – Phathom), a potassium-competitive acid blocker, for healing and maintenance of healing of all grades of erosive esophagitis and relief of associated heartburn in...
- Tirzepatide (Zepbound) for Chronic Weight Management The injectable glucose-dependent insulinotropic polypeptide (GIP)/glucagon-like peptide-1 (GLP-1) receptor agonist tirzepatide, which was approved by the FDA as Mounjaro for treatment of type 2 diabetes in...
- In Brief: Three New Injectable Antipsychotic Drugs Three extended-release injectable formulations of second-generation antipsychotic drugs — two of risperidone (Rykindo, Uzedy) and one of aripiprazole (Abilify Asimtufii) — have been approved by the...
- 2023 Annual Index (Online Only) View the 2023 Annual Index