The oral Janus kinase (JAK) inhibitor baricitinib (Olumiant – Lilly) has been granted an FDA Emergency Use Authorization (EUA) for treatment of confirmed or suspected COVID-19 in hospitalized patients ≥2 years old who require supplemental oxygen, mechanical ventilation, or extracorporeal membrane oxygenation (ECMO); the EUA requires that baricitinib be used in combination with the IV antiviral drug remdesivir (Veklury). Baricitinib has been available for treatment of rheumatoid arthritis since 2018. Remdesivir was recently approved by the FDA for treatment of COVID-19 in...

The FDA has approved an expansion of the peripheral artery disease (PAD) indication for the oral direct factor Xa inhibitor rivaroxaban (Xarelto – Janssen) to include patients who have recently undergone a lower extremity revascularization procedure for symptomatic PAD (see Table 1). Rivaroxaban is the first direct oral anticoagulant (DOAC) to be approved for use in patients with PAD.

Odevixibat (Bylvay – Albireo), an oral ileal bile acid transporter (IBAT) inhibitor, has been approved by the FDA for treatment of pruritus in patients ≥3 months old with progressive familial intrahepatic cholestasis (PFIC). It is the first drug to be approved in the US for this indication.

Olsalazine sodium (Dipentum - Pharmacia), a dimer (two molecules linked by an azo bond) of 5-aminosalicylic acid, was recently approved by the US Food and Drug Administration for oral use to maintain remission of ulcerative colitis in adult patients who cannot tolerate sulfasalazine (Azulfidine; and others).

The FDA has approved an inhaled fixed-dose combination of the long-acting anticholinergic umeclidinium (ue mek" li din' ee um) and the long-acting beta₂-adrenergic agonist (LABA) vilanterol (Anoro Ellipta – GSK/Theravance) for once-daily maintenance treatment of chronic obstructive pulmonary disease (COPD). Anoro Ellipta is the first product available in the US that combines two long-acting bronchodilators in a single delivery device.

Empagliflozin (Jardiance – Boehringer Ingelheim/Lilly), an SGLT2 inhibitor, has been approved by the FDA for oral treatment of type 2 diabetes. It is the third SGLT2 inhibitor to be approved for this indication.

The FDA has approved a fixed-dose combination of the integrase strand transfer inhibitor (INSTI) elvitegravir, the pharmacokinetic enhancer cobicistat, and the nucleoside/nucleotide reverse transcriptase inhibitors (NRTIs) emtricitabine and tenofovir disoproxil fumarate (Stribild – Gilead) for treatment of HIV-1 infection in antiretroviral treament-naïve adults. Elvitegravir is the second INSTI to be approved by the FDA for use in HIV treatment; raltegravir (Isentress) was the first.

At the same time that the FDA announced it was strengthening existing warnings about the risk of acute kidney injury in patients with type 2 diabetes treated with the sodium-glucose co-transporter 2 (SGLT2) inhibitors canagliflozin (Invokana, and others) and dapagliflozin (Farxiga, and others), a study was published showing that the third SGLT2 inhibitor, empagliflozin (Jardiance, and others), slowed the progression of renal dysfunction in patients with type 2 diabetes.

The FDA has approved nusinersen (Spinraza – Biogen) for treatment of spinal muscular atrophy (SMA), a hereditary neurodegenerative disease that occurs in about one in every 10,000 births. It is the first drug to be approved in the US for this indication.

Deflazacort (Emflaza – PTC Therapeutics), an oral corticosteroid, has been approved by the FDA for treatment of Duchenne muscular dystrophy (DMD) in patients ≥5 years old. It has been available outside the US for many years. Deflazacort is the second drug to be approved for treatment of DMD; eteplirsen (Exondys 51), an antisense oligonucleotide approved for IV administration in patients with mutations of the dystrophin gene amenable to exon 51 skipping (about 13% of DMD cases), was the first.