Linagliptin (Tradjenta – Boehringer Ingelheim/Lilly), a third oral dipeptidyl peptidase-4 (DPP-4) enzyme inhibitor, was recently approved by the FDA for treatment of type 2 diabetes, either alone or in combination with metformin, a sulfonylurea or pioglitazone

The FDA has approved a fixed-dose combination (Harvoni [har voe' nee] – Gilead) of sofosbuvir and ledipasvir (led' i pas' vir), two oral direct-acting antiviral agents, for treatment of chronic hepatitis C virus (HCV) genotype 1 infection. Genotype 1 is responsible for 70-80% of HCV infections in the US. Sofosbuvir (Sovaldi) was approved earlier for use in combination with other antiviral drugs for treatment of HCV infection. Ledipasvir is a new drug.

The FDA has approved eluxadoline (Viberzi – Actavis), a mu-opioid receptor agonist and delta-opioid receptor antagonist, for oral treatment of adults with irritable bowel syndrome with diarrhea (IBS-D).

The FDA has approved a progestin-only oral contraceptive ("minipill") containing drospirenone (Slynd – Exeltis). All other progestin-only oral contraceptives available in the US contain norethindrone (Camila, and others). Progestin-only oral contraceptives are similar in efficacy to combination oral contraceptives. They are used predominantly by breastfeeding women and by those in whom estrogen is poorly tolerated or contraindicated. Combination oral contraceptives containing drospirenone and ethinyl estradiol have been available for years.

The FDA has approved anifrolumab-fnia (Saphnelo – AstraZeneca), a type I interferon receptor antagonist, for IV treatment of adults with moderate to severe systemic lupus erythematosus (SLE) who are receiving standard treatment. Anifrolumab has not been studied in patients with severe active lupus nephritis or severe active CNS lupus. It is the first type I interferon receptor antagonist to become available in the US.

Maribavir (Livtencity – Takeda), an oral cytomegalovirus (CMV) pUL97 kinase inhibitor, has been approved by the FDA for treatment of post-transplant CMV infection refractory to standard antiviral therapy in patients ≥12 years old who weigh at least 35 kg.

Opdualag (BMS), a fixed-dose combination of two immune checkpoint inhibitors — nivolumab (Opdivo), a programmed death receptor-1 (PD-1) inhibitor, and relatlimab-rmbw, a lymphocyte-activation gene-3 (LAG-3) blocking antibody — has been approved by the FDA for treatment of unresectable or metastatic melanoma in patients ≥12 years old. Relatlimab, which is only available in combination with nivolumab, is the first LAG-3 blocking antibody to become available in the US. Immune checkpoint inhibitors, including the anti-CTLA-4 antibody ipilimumab (Yervoy) and the PD-1 inhibitors...

Toripalimab-tpzi (Loqtorzi – Coherus Biosciences), a programmed death receptor-1 (PD-1)-blocking antibody, has been approved by the FDA for use in combination with cisplatin and gemcitabine for first-line treatment of recurrent locally advanced or metastatic nasopharyngeal carcinoma and for use as monotherapy for treatment of recurrent unresectable or metastatic nasopharyngeal carcinoma in adults with disease progression on or after platinum-based chemotherapy. It is the first immune checkpoint inhibitor to be approved in the US for treatment of nasopharyngeal carcinoma.

The FDA has approved donislecel-jujn (Lantidra – CellTrans), an allogeneic pancreatic islet cellular therapy, for use in conjunction with immunosuppression for treatment of adults with type 1 diabetes who are unable to approach target HbA1c because of current repeated episodes of severe hypoglycemia despite intensive diabetes management and education. Donislecel is the first cell-based treatment to be approved in the US for type 1 diabetes.

Resmetirom (Rezdiffra – Madrigal), a thyroid hormone receptor-beta agonist, has received accelerated approval from the FDA for treatment of noncirrhotic nonalcoholic steatohepatitis (NASH) with moderate to advanced fibrosis in adults. NASH has recently been renamed metabolic dysfunction-associated steatohepatitis (MASH). Resmetirom is the first drug to be approved in the US for this indication.