The FDA has approved degarelix (Firmagon - Ferring), a synthetic decapeptide gonadotropin-releasing hormone (GnRH) receptor antagonist, for rapid medical castration of men with advanced prostate cancer. Abarelix (Plenaxis), the first GnRH antagonist approved by the FDA, was withdrawn from the US market because of immediate hypersensitivity reactions.

The FDA has approved ceftolozane/tazobactam (Zerbaxa – Cubist), a combination of a new cephalosporin antibiotic and a beta-lactamase inhibitor, for intravenous treatment of complicated urinary tract and intra-abdominal infections in adults.

The FDA has approved suvorexant (Belsomra – Merck), the first orexin receptor antagonist to become available in the US, for treatment of sleep-onset and/or sleep-maintenance insomnia.

The FDA has approved edoxaban (Savaysa – Daiichi Sankyo), a once-daily, oral, direct factor Xa inhibitor, for treatment of venous thromoboembolism (VTE) and for prevention of stroke and systemic embolism in patients with nonvalvular atrial fibrillation. It is the fourth new oral anticoagulant to be approved for VTE and nonvalvular atrial fibrillation.

The FDA has approved Odefsey (Gilead), a once-daily, fixed-dose combination of the non-nucleoside reverse transcriptase inhibitor (NNRTI) rilpivirine and the nucleoside/nucleotide reverse transcriptase inhibitors (NRTIs) emtricitabine and tenofovir alafenamide, for initial treatment of HIV-1 infection in patients with HIV-1 RNA (viral load) ≤100,000 copies/mL or to replace a stable antiretroviral regimen in patients who have been virologically suppressed (viral load <50 copies/mL) for at least six months with no history of treatment failure.

The FDA has approved Epclusa (Gilead), a fixed-dose combination of sofosbuvir (Sovaldi) and velpatasvir, a new direct-acting antiviral agent, for oral treatment of chronic hepatitis C virus (HCV) infection. Epclusa is the first oral combination to be approved for treatment of all six major HCV genotypes.

The FDA has approved daclizumab (Zinbryta – Biogen/Abbvie), an interleukin-2 (IL-2) receptor blocking monoclonal antibody, for treatment of adults with relapsing forms of multiple sclerosis (MS). It is the first subcutaneously injected monoclonal antibody to be approved for treatment of MS.

The FDA has approved a fixed-dose combination of the long-acting anticholinergic glycopyrrolate and the long-acting beta2-adrenergic agonist (LABA) formoterol (Bevespi Aerosphere – AstraZeneca) for long-term maintenance treatment of patients with chronic obstructive pulmonary disease (COPD). Glycopyrrolate/formoterol is the fourth long-acting anticholinergic/LABA combination to be approved in the US, but the first to become available in a metered-dose inhaler. Glycopyrrolate/indacaterol (Utibron Neohaler), umeclidinium/vilanterol (Anoro Ellipta), and tiotropium/olodaterol (Stiolto...

The FDA has approved the interleukin (IL)-6 inhibitor sarilumab (Kevzara – Sanofi) for second-line treatment of adults with moderately to severely active rheumatoid arthritis (RA). It is the second IL-6 inhibitor to be approved for this indication; tocilizumab (Actemra) was approved earlier.

Eravacycline (Xerava – Tetraphase), a new synthetic tetracycline antibiotic, has been approved by the FDA for IV treatment of complicated intra-abdominal infections (cIAIs) in adults. Eravacycline is structurally similar to tigecycline (Tygacil, and generics), a broad-spectrum tetracycline approved by the FDA for IV treatment of complicated skin and skin structure infections, complicated intra-abdominal infections, and community-acquired pneumonia. A higher rate of mortality has been reported with use of tigecycline compared to other antibacterial drugs; it should be used only...