Merck said the U.S. Food and Drug Administration has approved Lipfendra (enlicitide), making it the first oral PCSK9 inhibitor approved to treat high LDL, or "bad," cholesterol, reported by Reuters.
According to the report, the once-daily pill offers an alternative to injectable PCSK9 inhibitors currently dominating the cholesterol treatment market.
The FDA based its decision on two late-stage clinical trials showing the drug significantly lowered LDL cholesterol in patients, including those with familial hypercholesterolemia and individuals already taking statins.
Reuters reported that the approval supports Merck's strategy to diversify beyond its blockbuster cancer drug Keytruda, which is expected to face biosimilar competition after key patent protections begin expiring in 2028.
Analysts estimate Lipfendra could eventually generate tens of billions of dollars in peak annual sales.
Related Tweet:
Breaking News: The FDA approved a daily pill that can lower cholesterol levels far below what statins can, clinical trials have shown. https://t.co/dTUtOXn4Wk
— The New York Times (@nytimes) July 16, 2026
Also Read:
TIPP Staff
