The Medical Letter - 2024
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August 5, 2024 (Issue 1708)
- Drugs for Epilepsy When used for the appropriate seizure type, antiseizure medications (ASMs) are roughly equivalent in efficacy. In addition to the seizure type, the choice of drug is usually based on factors such as ease of...
- Comparison Table: Some Oral Antiseizure Medications (online only) View the Comparison Table: Some Oral Antiseizure Medications
July 22, 2024 (Issue 1707)
- In Brief: RSV Vaccine (Arexvy) for Ages 50-59 The recombinant respiratory syncytial virus (RSV) vaccine Arexvy (GSK) has now received FDA approval for use in adults 50-59 years old who are at increased risk for lower respiratory tract disease (LRTD)...
- Iloprost (Aurlumyn) for Frostbite The FDA has approved Aurlumyn (Eicos Sciences), an IV formulation of the prostacyclin analog iloprost, to reduce the risk of digit amputation in adults with severe frostbite. Iloprost is the first drug to...
- Iloperidone (Fanapt) — A New Indication for Bipolar Disorder The oral second-generation antipsychotic drug iloperidone (Fanapt – Vanda) has been approved by the FDA for acute treatment of manic or mixed episodes associated with bipolar I disorder in adults. First...
- Cefepime/Enmetazobactam (Exblifep) for Complicated Urinary Tract Infections The FDA has approved Exblifep (Allecra), a fixed-dose combination of the cephalosporin cefepime and the beta-lactamase inhibitor enmetazobactam, for IV treatment of adults with complicated urinary...
- In Brief: Wezlana — An Ustekinumab Biosimilar Interchangeable with Stelara The FDA has approved ustekinumab-auub (Wezlana – Amgen), an interchangeable biosimilar product similar to the interleukin-12 and -23 antagonist Stelara, for treatment of the same indications as Stelara...
- In Brief: Doxycycline for STI Post-Exposure Prophylaxis The CDC has issued a recommendation for use of a single dose of doxycycline for post-exposure prophylaxis (PEP) of bacterial sexually transmitted infections (STIs), specifically syphilis, chlamydia,...
- DaxibotulinumtoxinA (Daxxify) for Frown Lines (online only) The FDA has approved daxibotulinumtoxinA-lanm (Daxxify – Revance), an acetylcholine release inhibitor and neuromuscular blocking agent, for temporary improvement in the appearance of moderate to...
- Nifurtimox (Lampit) for Chagas Disease (online only) The FDA has approved the nitrofuran antiprotozoal drug nifurtimox (Lampit – Bayer) for treatment of Chagas disease (American trypanosomiasis) in children who weigh ≥2.5 kg. Nifurtimox was previously...
July 8, 2024 (Issue 1706)
- Drugs for Postmenopausal Osteoporosis Pharmacologic treatment is recommended for postmenopausal women who have bone density T-scores (standard deviations from normal mean values in the spine, femoral neck, total hip, or distal radius) of -2.5...
- Comparison Table: Some Drugs for Postmenopausal Osteoporosis (online only) View the Comparison Table: Some Drugs for Postmenopausal Osteoporosis
- Tarlatamab (Imdelltra) for Small Cell Lung Cancer (online only) Tarlatamab-dlle (Imdelltra – Amgen), a first-in-class bispecific delta-like ligand 3 (DLL3)-directed CD3 T-cell engager, has received accelerated approval from the FDA for treatment of...
- Trofinetide (Daybue) for Rett Syndrome (online only) Trofinetide (Daybue – Acadia), a synthetic analog of glycine-proline-glutamate, has been approved by the FDA for treatment of Rett syndrome in patients ≥2 years old. It is the first drug to be approved...
June 24, 2024 (Issue 1705)
- Gepirone (Exxua) for Depression The FDA has approved an oral extended-release formulation of gepirone (Exxua – Fabre-Kramer), a selective 5-HT1A receptor agonist, for treatment of major depressive disorder (MDD) in adults. Gepirone was...
- Lotilaner (Xdemvy) for Demodex Blepharitis The FDA has approved a 0.25% ophthalmic solution of the ectoparasiticide lotilaner (Xdemvy – Tarsus) for treatment of Demodex blepharitis. Lotilaner is the first drug to be approved in the US for this...
- Ophthalmic Phentolamine (Ryzumvi) for Drug-Induced Mydriasis The FDA has approved a 0.75% ophthalmic solution of the alpha-adrenergic antagonist phentolamine (Ryzumvi – Viatris) for treatment of mydriasis produced by adrenergic agonists such as phenylephrine or...
- Rezafungin (Rezzayo) for Invasive Candida Infections The FDA has approved rezafungin (Rezzayo – Cidara/Melinta), an intravenous echinocandin antifungal, for once-weekly treatment of candidemia and invasive candidiasis (IC) in adults with limited or no...
- In Brief: Anktiva for Bladder Cancer (online only) Nogapendekin alfa inbakicept-pmln (Anktiva – ImmunityBio), a first-in-class interleukin-15 (IL15) receptor agonist, has been approved by the FDA for use with Bacillus Calmette-Guérin (BCG) for...
- Tebentafusp (Kimmtrak) for Uveal Melanoma (online only) The FDA has approved tebentafusp-tebn (Kimmtrak – Immunocore), a first-in-class bispecific gp100 peptide-HLA-directed CD3 T-cell engager, for treatment of HLA-A*02:01-positive unresectable or metastatic...
- Tisotumab Vedotin (Tivdak) for Cervical Cancer (online only) Tisotumab vedotin-tftv (Tivdak – Seagen/Genmab), a tissue factor-directed antibody and microtubule inhibitor conjugate, has received full approval from the FDA for treatment of recurrent or metastatic...
- Correction Our recent article on Drugs for Hypertension (Med Lett Drugs Ther 2024; 66:81) described both the Paradise and Symplicity Spyral renal denervation devices as ultrasound devices. That is true for the Paradise...
June 10, 2024 (Issue 1704)
- Drugs for Head Lice Pediculosis capitis (head lice infestations) occur in all age groups, but especially in elementary school children. In most cases, transmission occurs by head-to-head contact. Pharmacologic treatment...
- Aprocitentan (Tryvio) for Hypertension The FDA has approved the dual endothelin receptor antagonist aprocitentan (Tryvio – Idorsia) for use in combination with other antihypertensive drugs to treat hypertension in adults whose blood pressure...
- Budesonide Oral Suspension (Eohilia) for Eosinophilic Esophagitis Eohilia (Takeda), an oral suspension formulation of the corticosteroid budesonide, has been approved by the FDA for treatment of eosinophilic esophagitis (EoE) in patients ≥11 years old. It is the first...
- Beqvez — Another Gene Therapy for Hemophilia B Fidanacogene elaparvovec-dzkt (Beqvez – Pfizer), an adeno-associated virus (AAV) vector-based gene therapy, has been approved by the FDA for treatment of adults with moderate to severe hemophilia B who do...
- Addendum: Relyvrio Withdrawn Relyvrio, the fixed-dose combination of sodium phenyl-butyrate and taurursodiol that received accelerated approval for treatment of amyotrophic lateral sclerosis (ALS) in 2022 based on a phase 2 trial...
- Tovorafenib (Ojemda) for Pediatric Low-Grade Glioma (online only) Tovorafenib (Ojemda – Day One), a type II RAF kinase inhibitor, has received accelerated approval from the FDA for treatment of patients ≥6 months old with relapsed or refractory pediatric low-grade...
May 27, 2024 (Issue 1703)
- Drugs for Hypertension American College of Cardiology/American Heart Association (ACC/AHA) guidelines for treatment of hypertension were last published in 2018. Treatment of hypertensive urgencies and emergencies is not discussed...
May 13, 2024 (Issue 1702)
- Sotatercept (Winrevair) for Pulmonary Arterial Hypertension The FDA has approved sotatercept-csrk (Winrevair – Merck), a first-in-class activin signaling inhibitor, to increase exercise capacity, improve WHO functional class, and reduce the risk of clinical...
- A New Indication for Bempedoic Acid (Nexletol) The oral adenosine triphosphate-citrate lyase (ACL) inhibitor bempedoic acid was approved by the FDA in 2020 for use alone (Nexletol – Esperion) and in a fixed-dose combination with the...
- Sarilumab (Kevzara) for Polymyalgia Rheumatica The FDA has approved the interleukin (IL)-6 inhibitor sarilumab (Kevzara – Sanofi/Regeneron) for treatment of polymyalgia rheumatica (PMR) in adults who had an inadequate response to corticosteroids...
- In Brief: Casgevy for Beta Thalassemia Exagamglogene autotemcel (Casgevy – Vertex), a cell-based gene therapy recently approved for treatment of sickle cell disease1, has now been approved by the FDA for treatment of patients ≥12 years old...
- COVID-19 Update: An EUA for Pemivibart (Pemgarda) for Pre-Exposure Prophylaxis The FDA has issued an Emergency Use Authorization (EUA) for the long-acting investigational IV monoclonal antibody pemivibart (Pemgarda – Invivyd) for pre-exposure prophylaxis of COVID-19 in persons ≥12...
- Eflornithine (Iwilfin) for High-Risk Neuroblastoma (online only) Eflornithine (Iwilfin – US WorldMeds), an oral ornithine decarboxylase inhibitor, has been approved by the FDA to reduce the risk of relapse in children and with high-risk neuroblastoma who had at least a...
- Erdafitinib (Balversa) for Urothelial Carcinoma (online only) Erdafitinib (Balversa – Janssen), an oral kinase inhibitor, has received full approval from the FDA for treatment of locally advanced or metastatic urothelial carcinoma in adults with susceptible FGFR3...
- Tislelizumab (Tevimbra) for Esophageal Cancer (online only) The FDA has approved tislelizumab (Tevimbra – BeiGene), a programmed death receptor-1 (PD-1) blocking antibody, for treatment of unresectable or metastatic esophageal squamous cell cancer in adults who...
April 29, 2024 (Issue 1701)
- Resmetirom (Rezdiffra) for Metabolic Dysfunction-Associated Steatohepatitis Resmetirom (Rezdiffra – Madrigal), a thyroid hormone receptor-beta agonist, has received accelerated approval from the FDA for treatment of noncirrhotic nonalcoholic steatohepatitis (NASH) with...
- A New Indication for Semaglutide (Wegovy) The injectable glucagon-like peptide-1 (GLP-1) receptor agonist semaglutide (Wegovy) has been approved by the FDA to reduce the risk of major adverse cardiovascular events (MACE) in adults with established...
- Intravenous Acetaminophen/Ibuprofen (Combogesic IV) The FDA has approved Combogesic IV (Hikma), an IV solution containing acetaminophen and ibuprofen, to treat mild to moderate pain (alone) or moderate to severe pain (in combination with an opioid) in...
- iDose TR — A Travoprost Implant for Glaucoma The FDA has approved iDose TR (Glaukos), an intracameral implant containing the prostaglandin analog (PGA) travoprost, for reduction of intraocular pressure (IOP) in patients with open-angle glaucoma or...
- Antibiotic Prophylaxis for Dental Procedures Since 2007, antimicrobial prophylaxis for dental procedures has been recommended to prevent viridans group streptococcal infective endocarditis only for patients at highest risk of an adverse outcome....
- Tepotinib (Tepmetko) for NSCLC (online only) The FDA has granted regular approval to the oral kinase inhibitor tepotinib (Tepmetko – EMD Serono) for treatment of adults with metastatic non-small cell lung cancer (NSCLC) harboring...
- Belzutifan (Welireg) for Advanced Renal Cell Carcinoma (online only) Belzutifan (Welireg – Merck), a first-in-class hypoxia-inducible factor inhibitor, has been approved by the FDA for treatment of advanced renal cell carcinoma (RCC) in adults who received prior treatment...
- Lifileucel (Amtagvi): A Cellular Therapy for Melanoma (online only) Lifileucel (Amtagvi – Iovance), a tumor-derived autologous T-cell immunotherapy, has received accelerated approval from the FDA for one-time treatment of adults with unresectable or metastatic melanoma...
April 15, 2024 (Issue 1700)
- Roflumilast Foam (Zoryve) for Seborrheic Dermatitis The FDA has approved a 0.3% foam formulation of the phosphodiesterase-4 (PDE4) inhibitor roflumilast (Zoryve – Arcutis) for topical treatment of seborrheic dermatitis in patients ≥9 years old....
- Cabtreo: A Three-Drug Gel for Acne The FDA has approved Cabtreo (Bausch Health), a gel containing the retinoid adapalene, the oxidizing agent benzoyl peroxide, and the antibiotic clindamycin, for treatment of acne vulgaris in patients ≥12...
- Zilucoplan (Zilbrysq) for Myasthenia Gravis The FDA has approved the complement C5 inhibitor zilucoplan (Zilbrysq – UCB) for once-daily subcutaneous treatment of generalized myasthenia gravis (gMG) in adults who are anti-acetylcholine receptor...
- Donislecel (Lantidra) for Type 1 Diabetes The FDA has approved donislecel-jujn (Lantidra – CellTrans), an allogeneic pancreatic islet cellular therapy, for use in conjunction with immunosuppression for treatment of adults with type 1 diabetes who...
April 1, 2024 (Issue 1699)
- Drugs for Bipolar Disorder Bipolar disorder is characterized by episodes of mania, hypomania, and depression. Recurrences of manic or (more frequently) depressive symptoms are common. About 15-20% of patients with bipolar disorder...
- Omalizumab (Xolair) for Food Allergy Omalizumab (Xolair – Genentech), a recombinant anti-IgE monoclonal antibody FDA-approved for treatment of allergic asthma, chronic rhinosinusitis with nasal polyps, and chronic urticaria, has now also...
- Addendum: Bupropion Safety in Pregnancy Our December 11, 2023 article on Drugs for Depression included a single sentence on the safety of bupropion use during pregnancy: "The safety of bupropion during pregnancy has not been established; data from...
March 18, 2024 (Issue 1698)
- Airsupra: An Inhaled Albuterol/Budesonide Combination for Asthma The FDA has approved Airsupra (AstraZeneca), a metered-dose inhaler containing the short-acting beta2-agonist (SABA) albuterol and the inhaled corticosteroid (ICS) budesonide, for use as needed...
- Penbraya: A Pentavalent Meningococcal Vaccine The FDA has licensed Penbraya (Pfizer), a pentavalent polysaccharide conjugate meningococcal vaccine, for prevention of invasive meningococcal disease caused by Neisseria meningitidis serogroups A, B, C, W,...
- Mirikizumab (Omvoh) for Ulcerative Colitis The FDA has approved the interleukin (IL)-23 antagonist mirikizumab-mrkz (Omvoh – Lilly) for treatment of moderately to severely active ulcerative colitis (UC) in adults. Mirikizumab is the first...
- In Brief: A New OTC Naloxone Nasal Spray (RiVive) The FDA has approved RiVive (Harm Reduction Therapeutics), a 3-mg naloxone nasal spray, as an over-the-counter (OTC) product for emergency treatment of opioid overdose. Two 4-mg naloxone nasal spray...
March 4, 2024 (Issue 1697)
- Drugs for Menopausal Symptoms The primary symptoms of menopause are genitourinary and vasomotor. The genitourinary syndrome of menopause (GSM) includes symptoms such as burning, irritation, dryness, dyspareunia, dysuria, and recurrent...
- Tenapanor (Xphozah) for Hyperphosphatemia in Chronic Kidney Disease The FDA has approved the sodium/hydrogen exchanger 3 (NHE3) inhibitor tenapanor (Xphozah – Ardelyx) to reduce serum phosphorus in adults with chronic kidney disease (CKD) on dialysis as add-on therapy...
- In Brief: Severe Hypocalcemia with Denosumab (Prolia) in Chronic Kidney Disease The FDA is requiring a boxed warning in the label of denosumab (Prolia – Amgen), a monoclonal antibody that inhibits osteoclasts, about an increased risk of severe hypocalcemia in patients with advanced...
February 19, 2024 (Issue 1696)
- Daprodustat (Jesduvroq) for Anemia of Chronic Kidney Disease The FDA has approved daprodustat (Jesduvroq – GSK), a hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI), for oral treatment of anemia due to chronic kidney disease (CKD) in adults who...
- Cantharidin Topical Solution (Ycanth) for Molluscum Contagiosum The FDA has approved cantharidin 0.7% solution (Ycanth – Verrica) for topical treatment of molluscum contagiosum in patients ≥2 years old. Ycanth was the first drug to be approved in the US for...
- Rozanolixizumab (Rystiggo) for Myasthenia Gravis Rozanolixizumab-noli (Rystiggo – UCB), a neonatal Fc receptor (FcRn) blocker, has been approved by the FDA for treatment of generalized myasthenia gravis in adults with anti-acetylcholine receptor (AChR)...
- Balfaxar: Another Four-Factor PCC for Warfarin Reversal Balfaxar (Octapharma), a human plasma-derived four-factor prothrombin complex concentrate (PCC), has been approved by the FDA for rapid reversal of warfarin anticoagulation in adults who require an urgent...
- Capivasertib (Truqap) for Breast Cancer (online only) The oral kinase inhibitor capivasertib (Truqap – AstraZeneca), a first-in-class AKT inhibitor, has been approved by the FDA for use in combination with the selective estrogen receptor degrader...
- Fruquintinib (Fruzaqla) for Metastatic Colorectal Cancer (online only) Fruquintinib (Fruzaqla – Takeda), an oral kinase inhibitor, has been approved by the FDA for treatment of adults with metastatic colorectal cancer (mCRC) who received prior fluoropyrimidine-, oxaliplatin-,...
- Repotrectinib (Augtyro) for Non-Small Cell Lung Cancer (online only) The FDA has approved the oral tyrosine kinase inhibitor repotrectinib (Augtyro – BMS) for treatment of locally advanced or metastatic ROS1-positive non-small cell lung cancer (NSCLC) in...
February 5, 2024 (Issue 1695)
- Drugs for Acne Acne is common among adolescents and adults. Guidelines for treatment of acne were last published by the American Academy of Dermatology in 2016.
- Drugs for Rosacea Rosacea is a common, chronic inflammatory facial eruption of unknown cause. It is more prevalent in women than in men, and disease onset typically occurs after age 30. Rosacea is characterized by erythema,...
- Comparison Table: Some Topical Drugs for Rosacea (online only) View the Comparison Table: Some Topical Drugs for Rosacea
- IV Ferric Carboxymaltose (Injectafer) for Iron Deficiency in Heart Failure Ferric carboxymaltose (Injectafer – American Regent) is now FDA-approved for IV treatment of iron deficiency in adults with New York Heart Association (NYHA) class II/III heart failure to improve...
- Addendum: Drugs for Depression In our article on Drugs for Depression, we should have included tardive dyskinesia (TD) in our list of adverse effects of second-generation antipsychotic (SGA) drugs. TD, which is more commonly associated...
- Addendum: Treatment of Atrial Fibrillation The Interruption of Anticoagulation section of our article on Treatment of Atrial Fibrillation cited the recommendations of the American College of Chest Physicians on perioperative management of antithrombotic...
- In Memoriam Neal H. Steigbigel, M.D. of New York University School of Medicine died on January 13, 2024. His name has been on the masthead of The Medical Letter, fi rst as a member of the Advisory Board and then as a...
January 22, 2024 (Issue 1694)
- Casgevy and Lyfgenia: Two Gene Therapies for Sickle Cell Disease Two cell-based gene therapies – exagamglogene autotemcel (Casgevy – Vertex) and lovotibeglogene autotemcel (Lyfgenia – Bluebird Bio) – have been approved by the FDA for treatment of sickle...
- Bimekizumab (Bimzelx) for Psoriasis The FDA has approved the injectable interleukin (IL)-17A/17F antagonist bimekizumab-bkzx (Bimzelx – UCB) for treatment of moderate to severe plaque psoriasis in adults who are candidates for...
- Perfluorohexyloctane Ophthalmic Solution (Miebo) for Dry Eye Disease The FDA has approved perfluorohexyloctane ophthalmic solution (Miebo – Bausch+Lomb) for treatment of dry eye disease. Available only by prescription, Miebo is the first ophthalmic product to be approved in...
- Avacincaptad Pegol (Izervay) for Geographic Atrophy in Age-Related Macular Degeneration The FDA has approved the complement C5 inhibitor avacincaptad pegol (Izervay – Iveric) for intravitreal treatment of geographic atrophy (GA) secondary to age-related macular degeneration...
- Toripalimab (Loqtorzi) for Nasopharyngeal Carcinoma (online only) Toripalimab-tpzi (Loqtorzi – Coherus Biosciences), a programmed death receptor-1 (PD-1)-blocking antibody, has been approved by the FDA for use in combination with cisplatin and gemcitabine for first-line...
January 8, 2024 (Issue 1693)
- Treatment of Atrial Fibrillation Atrial fibrillation (AF) is the most common arrhythmia in the world. Risk factor modification, anticoagulation, rhythm control, and rate control are the four pillars of its management. American College of...