FDA approves Lipfendra (enlicitide), the first once-daily oral PCSK9 cholesterol medicine

The FDA approved Merck's Lipfendra (enlicitide) 20 mg tablets as an add-on to diet and exercise for adults with hypercholesterolemia, including heterozygous familial hypercholesterolemia. It is the first oral PCSK9 inhibitor shown to lower LDL cholesterol, while existing PCSK9 drugs are injectables. The release gives no launch date or price.

• CORALreef Lipids: LDL-C down 56% vs placebo at week 24
• CORALreef HeFH: LDL-C down 59% vs placebo at week 24
• Approved for adults with hypercholesterolemia, including HeFH