The FDA has approved romidepsin (Istodax – Celgene), an IV histone deacetylase (HDAC) inhibitor, for treatment of cutaneous T-cell lymphoma (CTCL) in patients who have received at least one prior systemic therapy. The most common types of CTCL are mycosis fungoides, a low-grade lymphoma usually confined to the skin, and Sézary syndrome, a more aggressive disease with malignant lymphocytes in the blood. Both can progress to fatal systemic involvement. Romidepsin is the second HDAC inhibitor approved for this indication; vorinostat (Zolinza), an oral HDAC inhibitor, was approved...

The FDA has approved Trumenba (Pfizer), a vaccine that protects against invasive meningococcal disease caused by Neisseria meningitidis serogroup B, for use in adolescents and young adults 10-25 years old.

Vascular endothelial growth factor (VEGF) is a principal mediator of neovascularization in wet age-related macular degeneration (AMD) and diabetic macular edema. It induces angiogenesis and increases vascular permeability and inflammation. VEGF inhibitors reduce leakage from blood vessels, prevent proliferation of new abnormal vessels, decrease swelling of the retina, and improve visual acuity in patients with neovascular (wet) AMD and diabetic macular edema. These drugs are given as periodic intravitreal injections with topical anesthesia.

Rifaximin (Xifaxan – Salix), a minimally absorbed oral antibiotic approved previously to treat travelers' diarrhea and to reduce the risk of recurrent hepatic encephalopathy, has now been approved by the FDA for treatment of irritable bowel syndrome with diarrhea (IBS-D). Eluxadoline (Viberzi – Actavis), a mu-opioid receptor agonist, was also recently approved for IBS-D and will be reviewed in a future issue.

Evolocumab (Repatha – Amgen), a subcutaneously injected PCSK9 inhibitor, has been approved by the FDA as an adjunct to diet and maximally tolerated statin therapy for adults with heterozygous familial hypercholesterolemia (HeFH) or clinical atherosclerotic cardiovascular disease who require additional lowering of LDL-cholesterol (LDL-C). It was also approved as an adjunct to diet and other LDL-lowering therapies in patients with homozygous familial hypercholesterolemia (HoFH) who require additional lowering of LDL-C. Evolocumab is the second PCSK9 inhibitor to be approved in the...

The antiplatelet drug clopidogrel (Plavix, and others) reduces major cardiovascular events, but can cause bleeding. Proton pump inhibitors (PPIs) are often used with clopidogrel to prevent gastrointestinal bleeding, however, some evidence suggests that PPIs may interfere with the activation of clopidogrel and diminish its antiplatelet effect. FDA-approved labeling recommends avoiding concurrent use of the PPIs omeprazole and esomeprazole with clopidogrel.

The FDA has approved a subcutaneously administered 20% solution of human immune globulin (Cuvitru – Shire) for replacement therapy in patients ≥2 years old with a primary humoral immunodeficiency. Hizentra (CSL Behring), another subcutaneously administered 20% immune globulin solution, was approved in 2010 for the same indication. The IgG component of Cuvitru is similar to that of Gammagard Liquid and HyQvia, two subcutaneously administered 10% immune globulin formulations also manufactured by Shire and approved for treatment of primary...

The FDA has approved fostamatinib disodium hexahydrate (Tavalisse – Rigel), the first spleen tyrosine kinase (SYK) inhibitor, for oral treatment of thrombocytopenia in adults with chronic immune thrombocytopenia (ITP) who have had an insufficient response to a previous treatment.

The FDA has approved Duaklir Pressair (Circassia), a fixed-dose combination of the long-acting muscarinic antagonist (LAMA) aclidinium bromide and the longacting beta₂-adrenergic agonist (LABA) formoterol fumarate, for maintenance treatment of chronic obstructive pulmonary disease (COPD). Aclidinium/formoterol is the fifth LAMA/LABA combination to be approved in the US for this indication.

The FDA has approved peanut allergen powder-dnfp (Palforzia – Aimmune) for use as oral immunotherapy to mitigate allergic reactions, including anaphylaxis, caused by accidental peanut exposure in patients with a confirmed peanut allergy. It is the first drug to be approved in the US for this indication; Viaskin Peanut, an immunotherapy patch, is under FDA review for the same indication.