The FDA has approved the oral, once-daily, second-generation antipsychotic brexpiprazole (Rexulti – Otsuka/Lundbeck) for treatment of schizophrenia and as an adjunct to antidepressants for treatment of major depressive disorder (MDD). Aripiprazole (Abilify), a structurally similar second-generation antipsychotic also comarketed by Otsuka (with BMS), recently became available generically.

The FDA has approved ixekizumab (Taltz – Lilly), an injectable humanized interleukin (IL)-17A antagonist, for treatment of adults with moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy. Ixekizumab is the second IL-17A antagonist to be approved for this indication in the US; secukinumab (Cosentyx – Novartis) was the first.

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 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.

The FDA has approved cannabidiol oral solution (Epidiolex – Greenwich Biosciences) for treatment of seizures associated with Dravet syndrome or Lennox-Gastaut syndrome in patients ≥2 years old. Cannabidiol (CBD) is a cannabinoid constituent of the marijuana plant (Cannabis sativa). It is the first natural marijuana product to be approved by the FDA for any indication and the first drug to be approved in the US for treatment of Dravet syndrome. Stiripentol (Diacomit), which is not a marijuana product, was also recently approved by the FDA for treatment of Dravet syndrome in...

The FDA has approved the oral adenosine triphosphate-citrate lyase (ACL) inhibitor bempedoic acid for use alone (Nexletol – Esperion) and in a fixed-dose combination with the cholesterol absorption inhibitor ezetimibe (Nexlizet) as an adjunct to diet and maximally tolerated statin therapy in adults with heterozygous familial hypercholesterolemia (HeFH) or established atherosclerotic cardiovascular disease (ASCVD) who require additional lowering of LDL-cholesterol (LDL-C). Bempedoic acid is the first ACL inhibitor to be approved in the US.

The FDA has approved opicapone (Ongentys – Neurocrine), a peripherally-acting reversible catechol-O-methyltransferase (COMT) inhibitor, for oral use as an adjunct to carbidopa/levodopa in adults with Parkinson’s disease (PD) who experience "off" episodes. It is the third COMT inhibitor to be approved for this indication; tolcapone (Tasmar, and generics) and entacapone (Comtan, and generics) were approved earlier. Opicapone has been available in Europe since 2016.

The FDA has approved stiripentol (Diacomit – Biocodex) for treatment of seizures in patients ≥2 years old with Dravet syndrome who are also taking clobazam (Onfi). Stiripentol, which has been available in Europe, Canada, and Japan for many years, is the second drug to be approved in the US for this indication; cannabidiol oral solution (Epidiolex), a purified marijuana product, was the first.

View Expanded Table: Some Biologic Drugs and JAK Inhibitors for Rheumatoid Arthritis