Merck Secures FDA Approval for Oral PCSK9 Cholesterol Drug

MRK won U.S. FDA approval on July 16 for Lipfendra (generic name enlicitide), the first oral PCSK9 inhibitor cleared to lower LDL cholesterol. The once-daily pill is a novel macrocyclic peptide and represents a milestone for a drug class that until now required injections.

In Phase 3 trials, Lipfendra cut LDL-C by 56% to 59% versus placebo at 24 weeks, potency that rivals injectable PCSK9 therapies such as Amgen's Repatha. Approval covers adults with hypercholesterolemia, including heterozygous familial hypercholesterolemia; a cardiovascular-outcomes trial reading out around 2029 will determine whether the drug also reduces heart attacks and strokes.

For MRK, an oral option addresses the adherence gap that has limited injectable PCSK9 uptake and opens a potentially large primary-care market as the company works to offset looming Keytruda patent exposure. Pricing, payer coverage, and the pace of prescriber adoption are the near-term variables to watch.

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