The FDA has approved a two-dose hepatitis B virus (HBV) vaccine (Heplisav-B – Dynavax) for use in adults ≥18 years old. The three other HBV vaccines marketed in the US are usually administered in 3 doses. Engerix-B and Recombivax HB are licensed for use in persons of all ages. A combination hepatitis A/B vaccine (Twinrix) contains the same hepatitis B component as Engerix-B and is licensed for use only in adults.

The FDA has approved semaglutide (Ozempic – Novo Nordisk), a long-acting injectable GLP-1 (glucagon-like peptide-1) receptor agonist, for once-weekly treatment of adults with type 2 diabetes. It is the sixth GLP-1 receptor agonist to be approved in the US.

The FDA has approved an oral powder formulation of the amino acid L-glutamine (Endari – Emmaus) to reduce the acute complications of sickle cell disease in patients ≥5 years old. Endari is only the second drug to be approved for use in sickle cell disease; the antimetabolite hydroxyurea (Droxia) was approved 20 years ago. L-glutamine oral powder is also available by prescription as NutreStore for treatment of short bowel syndrome and over the counter as a dietary supplement.

A reader asked whether healthcare providers should avoid prescribing the angiotensin receptor blocker (ARB) olmesartan medoxomil (Benicar, and others) because it can cause severe GI adverse effects.In 2013, the FDA warned that olmesartan can cause sprue-like enteropathy, a condition characterized by intestinal villous atrophy, severe chronic diarrhea, and significant unintended weight loss. The warning was based on 23 cases of serious sprue-like enteropathy associated with use of olmesartan, some occurring years after starting the drug. All patients improved after stopping olmesartan; 10 had a...

The FDA has approved the oral tyrosine kinase inhibitor neratinib (Nerlynx – Puma Biotechnology) for extended adjuvant treatment of adults with early-stage, human epidermal growth factor receptor 2 (HER2)-positive breast cancer, following adjuvant trastuzumab (Herceptin)-based therapy. HER2 is overexpressed in about 20% of breast cancers. Up to 30% of early-stage, HER2-positive breast cancer cases treated with trastuzumab-based adjuvant therapy recur.

The FDA has warned that the IV emulsion formulation of the substance P/neurokinin 1 (NK1) receptor antagonist rolapitant (Varubi) has been associated in postmarketing reports with serious hypersensitivity reactions including anaphylaxis and anaphylactic shock.1 Rolapitant was approved by the FDA as an oral tablet in 2015 for adjunctive prevention of delayed nausea and vomiting associated with cancer chemotherapy in adults2; the IV emulsion formulation of the drug was approved for the same indication in 2017.The reported hypersensitivity reactions occurred during or shortly after infusion of...

The FDA has approved Fiasp (Novo Nordisk), a new formulation of insulin aspart, to improve glycemic control in adults with diabetes. Fiasp is described by the manufacturer as faster-acting than conventional insulin aspart (Novolog).

The FDA has approved an extended-release intramuscular suspension formulation of the gonadotropin-releasing hormone (GnRH) agonist triptorelin (Triptodur – Arbor/Debiopharm) for twice-yearly treatment of central precocious puberty (CPP) in children ≥2 years old. Triptorelin has been available in the US for years as Trelstar for palliative treatment of advanced prostate cancer. Before the approval of Triptodur, Trelstar was used off-label for treatment of CPP.

The FDA has approved betrixaban (Bevyxxa – Portola), a once-daily, oral, direct factor Xa inhibitor, for prophylaxis of venous thromboembolism (VTE) in adults hospitalized for an acute medical illness who have moderately or severely restricted mobility and other risk factors for VTE. Betrixaban is the first oral anticoagulant to be approved in the US for this indication.

The immune checkpoint inhibitor pembrolizumab (Keytruda – Merck), a programmed death receptor-1 (PD-1) inhibitor, has been granted accelerated approval by the FDA for use in adults and children who have unresectable or metastatic microsatellite-instability-high (MSI-H) or mismatch-repair-deficient (dMMR) solid tumors that have progressed following treatment, and do not have any satisfactory alternative treatment options. For metastatic colorectal cancer, the indication is limited to tumors that have progressed following combination treatment with a fluoropyrimidine, oxaliplatin, and...