Merck secures US approval for the first oral PCSK9 cholesterol-lowering pill, edging out AstraZeneca

Merck has received the United States regulatory clearance for an oral PCSK9 inhibitor, marking the first time a pill of this class has been approved for cholesterol management.

The approval comes ahead of AstraZeneca, which was also developing an oral PCSK9 therapy. Merck's faster regulatory timeline gave it a market advantage in the emerging oral cholesterol‑lowering segment.

The new drug could expand treatment options for patients who prefer a pill over injectable biologics, potentially reshaping the competitive landscape for lipid‑lowering therapies.