Merck’s FDA approval of enlicitide decanoate (Lipfendra) is the first once-daily oral PCSK9 inhibitor for adults with high LDL cholesterol, including heterozygous familial hypercholesterolemia. The clearance expands treatment options beyond existing PCSK9 approaches and is a meaningful regulatory milestone for the company.
Merck’s FDA approval of enlicitide decanoate (Lipfendra) is the first once-daily oral PCSK9 inhibitor for adults with high LDL cholesterol, including heterozygous familial hypercholesterolemia. The clearance expands treatment options beyond existing PCSK9 approaches and is a meaningful regulatory milestone for the company.
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