Merck's (MRK) Cholesterol Pill Lipfendra Gains FDA Approval

Merck (MRK) announced that the U.S. FDA approved Lipfendra, the first oral PCSK9 inhibitor for treating hypercholesterolemia. This approval comes as Merck's Keytruda faces patent expirations in 2028, which could lead to competition from biosimilars. Lipfendra's approval was based on late-stage trials demonstrating significant reductions in LDL cholesterol levels. Analysts suggest Lipfendra could have peak sales potential worth tens of billions of dollars. This matters for investors as Lipfendra diversifies Merck's offerings beyond oncology, potentially stabilizing revenue streams.