PCSK9 is the enzyme that controls LDL receptor levels, shaping cholesterol clearance and cardiovascular risk. It’s central to statin-addition therapies and novel lipid-lowering drugs.
The FDA has approved Lipfendra, Merck’s oral PCSK9 inhibitor, to lower LDL cholesterol in patients on statins. Trials show ~55-60% LDL reductions; the pill will be sold at about $315/month and must be taken on an empty stomach. Analysts see potential peak sales in the billions as injectable rivals face competition and access barriers.