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.

The FDA has approved an inhaled, rapid-acting, dry-powder formulation of recombinant human insulin (Afrezza – Mannkind/Sanofi) for treatment of adults with type 1 or type 2 diabetes. In patients with type 1 diabetes, the drug must be used in combination with long-acting insulin. Another inhaled, rapid-acting insulin (Exubera) was approved in 2006 for the same indication, but was withdrawn from the market the following year.

Immune globulin (IgG) has been available for administration intravenously once every 3-4 weeks or subcutaneously once daily, once weekly, or every 2 weeks for treatment of primary immunodeficiencies. Now the FDA has approved human immune globulin 10% with recombinant human hyaluronidase (HyQvia – Baxter) for subcutaneous administration only every 3-4 weeks in adults with these disorders. The IgG component of HyQvia is identical to Gammagard Liquid, which was approved in 2005 for IV administration and in 2011 for SC administration.

The FDA has approved racemic amphetamine sulfate (Evekeo – Arbor) for oral treatment of attention-deficit/hyperactivity disorder (ADHD) in children ≥3 years old. It was also approved for treatment of narcolepsy in patients ≥6 years old and for short-term treatment of obesity in patients ≥12 years old.

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 FDA has approved Synjardy (Boehringer Ingelheim/Lilly), a fixed-dose combination of the sodium-glucose co-transporter 2 (SGLT2) inhibitor empagliflozin (Jardiance) and metformin (Glucophage, and others), for treatment of patients with type 2 diabetes not adequately controlled on either of these drugs alone or already being treated with both empagliflozin and metformin. It is the third SGLT2 inhibitor/metformin combination to be approved in the US.

The FDA has approved elvitegravir (Vitekta – Gilead), an integrase strand transfer inhibitor (INSTI), for use with a protease inhibitor (PI) plus ritonavir and other antiretroviral drugs for treatment of HIV-1 infection in treatment-experienced adults. Elvitegravir is also available in a fixed-dose combination (Stribild) with the pharmacokinetic enhancer cobicistat and the nucleoside/nucleotide reverse transcriptase inhibitors (NRTIs) emtricitabine and tenofovir disoproxil fumarate (DF). A similar combination (Genvoya) that includes tenofovir alafenamide instead of tenofovir...

The FDA has approved the immune checkpoint inhibitor atezolizumab (Tecentriq – Genentech) for treatment of locally advanced or metastatic urothelial carcinoma and metastatic non-small cell lung cancer (NSCLC) that have progressed during or following platinum-based chemotherapy. Atezolizumab is the first programmed death-ligand 1 (PD-L1) blocking antibody to become available in the US. Two other immune checkpoint inhibitors, the programmed death receptor-1 (PD-1) inhibitors nivolumab (Opdivo) and pembrolizumab (Keytruda), are also approved for treatment of metastatic NSCLC, and...

The FDA has approved brodalumab (Siliq – Valeant), an injectable human interleukin (IL)-17A receptor antagonist, for treatment of adults with moderate to severe plaque psoriasis who have failed to respond to other systemic therapies. Brodalumab is the third IL-17A antagonist to be approved in the US for this indication; secukinumab (Cosentyx) and ixekizumab (Taltz) were approved earlier.

The FDA has approved an adjuvanted, recombinant varicella zoster virus (VZV) vaccine (Shingrix – GSK) for prevention of herpes zoster (shingles) in adults ≥50 years old. Shingrix is the second herpes zoster vaccine to be approved in the US; Zostavax, a live-attenuated VZV vaccine approved for the same indication, has been available since 2006.