Merck's Lipfendra lands FDA nod as oral PCSK9 cholesterol fighter

The FDA approved Lipfendra, Merck's oral cholesterol-lowering drug that blocks the PCSK9 protein, offering a non-injectable option to reduce LDL cholesterol by up to about 60% after 24 weeks in trials. It targets hypercholesterolemia (including familial forms) for patients often already on statins, expanding treatment beyond injectable PCSK9 inhibitors. Lipfendra is priced at $10.50 per day (about $315 for a 30‑day supply), with Merck signaling lower out‑of‑pocket costs. The approval aligns with evolving guidelines urging aggressive LDL targets to cut heart-disease and stroke risk.