Merck wins FDA nod for first oral PCSK9 inhibitor, Lipfendra, to treat high LDL cholesterol

Merck announced that the U.S. Food and Drug Administration has approved its once-daily oral PCSK9 inhibitor, enlicitide, marketed as Lipfendra, for adults with elevated LDL cholesterol.

The drug is the first oral PCSK9 therapy to receive approval, offering an alternative to injectable treatments and potentially improving patient convenience.

Approval was based on Phase 3 data from Merck’s CORALreef program, which showed a placebo-adjusted LDL reduction of about 59% after 24 weeks, including in patients with heterozygous familial hypercholesterolemia.

The decision came through the FDA’s Commissioner’s National Priority Voucher program, marking the ninth such approval, and puts Merck ahead of AstraZeneca, which is still developing its own oral candidate.