Merck's Lipfendra becomes first oral PCSK9 inhibitor, FDA approved, cuts LDL cholesterol 56-59% in Phase 3 trials
Merck $MRK got FDA approval for Lipfendra, the first pill form of a PCSK9 cholesterol drug. Prior versions, like Repatha, needed an injection every few weeks. Two Phase 3 trials showed the tablet cut LDL cholesterol 56% and 59% versus placebo at 24 weeks, removing that needle bar
The FDA has approved Lipfendra (enlicitide), a Merck $MRK drug that is the first oral PCSK9 inhibitor for high cholesterol, per the agency's July 16 announcement. PCSK9 inhibitors help the liver clear LDL cholesterol from the blood more effectively than statins alone, but every prior drug in this class, including Amgen's Repatha, required an injection every two to four weeks. Lipfendra is a once-daily 20mg tablet instead. In Merck's Phase 3 trials, the drug lowered LDL cholesterol by 56% in one study and 59% in a second, both measured against placebo at 24 weeks. It is approved for adults with high cholesterol, including those with heterozygous familial hypercholesterolemia, a genetic condition that causes dangerously high LDL levels from an early age. The practical shift here is access: injectable PCSK9 inhibitors carry a needle-related barrier that keeps some eligible patients from starting or staying on treatment. A pill removes that friction, which matters most for the many adults who don't reach their LDL targets on statins alone.