The FDA has approved Merck’s Lipfendra (enlicitide), a once-daily oral therapy to reduce low-density lipoprotein cholesterol in adults with high cholesterol or heterozygous familial hypercholesterolemia.
The approval was supported by two randomized, double-blind, placebo-controlled trials involving 3,207 adults already taking maximally tolerated statin therapy), according to a July 16 FDA news release. In patients with atherosclerotic cardiovascular disease or at high risk for the condition, Lipfendra reduced LDL cholesterol by 56% from baseline at 24 weeks compared with placebo. In adults with heterozygous familial hypercholesterolemia, the therapy reduced LDL cholesterol by 59% at 24 weeks compared with placebo.
Lipfendra is the first oral therapy that inhibits proprotein convertase subtilisin/kexin type 9 (PCSK9. It is approved for use with diet and exercise to lower LDL cholesterol.
