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 Tarpeyo (Calliditas), a delayed-release capsule formulation of the corticosteroid budesonide, to reduce proteinuria in adults with primary immunoglobulin A nephropathy (IgAN; also called Berger's disease) who are at risk of rapid disease progression. It is the fi rst drug to be approved in the US for this indication. Oral formulations of budesonide have been available for years for treatment of inflammatory bowel disease.

The oral kinase inhibitor pemigatinib (Pemazyre – Incyte) has received accelerated approval from the FDA for treatment of adults with previously treated, unresectable, locally advanced or metastatic cholangiocarcinoma with fibroblast growth factor receptor 2 (FGFR2) fusions or other rearrangements. Pemigatinib is the first drug to be approved in the US for this indication.

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.

Tovorafenib (Ojemda – Day One), a type II RAF kinase inhibitor, has received accelerated approval from the FDA for treatment of patients ≥6 months old with relapsed or refractory pediatric low-grade glioma harboring a BRAF fusion or rearrangement or a BRAF V600 mutation. Tovorafenib is the first systemic treatment to be approved in the US for pediatric low-grade gliomas with BRAF fusions. Accelerated approval of tovorafenib was based on response rates and duration of response.

Icosapent ethyl (Vascepa – Amarin), the ethyl ester of eicosapentaenoic acid (EPA), has been approved by the FDA for use as an adjunct to maximally tolerated statin therapy to reduce the risk of major adverse cardiovascular events in adults with hypertriglyceridemia (≥150 mg/dL) who have either established cardiovascular disease (CVD) or diabetes and ≥2 additional risk factors for CVD. It is the only omega-3 polyunsaturated fatty acid (PUFA) product to be approved in the US for this indication. Icosapent ethyl and two other omega-3 PUFA prescription products (Lovaza, Epanova),...

The FDA has approved cenobamate (Xcopri – SK Life Science) for oral treatment of partial-onset (focal) seizures in adults.

View the Comparison Table: Some Nonopioid Analgesics for Pain

Tezepelumab-ekko (Tezspire – AstraZeneca/Amgen), a subcutaneously administered thymic stromal lymphopoietin (TSLP) blocker, has been approved by the FDA for add-on maintenance treatment of severe asthma in patients ≥12 years old. It is the first TSLP blocker to become available in the US and the first biologic drug to be approved for treatment of severe asthma without phenotypic or biomarker limitations.

Adagrasib (Krazati – Mirati Therapeutics), a RAS GTPase family inhibitor, has received accelerated approval from the FDA for oral treatment of KRAS G12C-mutated locally advanced or metastatic non-small cell lung cancer (NSCLC) in adults who received at least one prior systemic therapy. Accelerated approval was based on the objective response rate and duration of response.