The US FDA has approved Merck’s Lipfendra, the first oral PCSK9 inhibitor, offering a pill-based alternative to injectable cholesterol drugs.
FDA Approves Merck’s Lipfendra, First Oral Cholesterol Pill of Its Kind
According to CNN, the approval strengthens Merck’s push to diversify beyond its cancer drug Keytruda, which faces patent expiry starting 2028. Lipfendra, also called enlicitide, treats hypercholesterolemia by blocking the PCSK9 protein and is based on two late-stage trials showing significant LDL reduction, including in patients with familial hypercholesterolemia. It joins a market currently led by injectables like Amgen’s Repatha and Regeneron/Sanofi’s Praluent. Scotiabank analyst Louise Chen had estimated peak sales potential “of tens of billions of dollars” ahead of the approval. The drug received a National Priority Voucher from the FDA commissioner, speeding up its review.
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