FDA approves first oral PCSK9 inhibitor Lipfendra for high cholesterol

The U.S. Food and Drug Administration has approved Lipfendra (enlicitide), the first oral inhibitor of the PCSK9 protein, for lowering LDL cholesterol in adults with hypercholesterolemia. Source: CNN, El Caribe

How it works

Lipfendra blocks the PCSK9 protein, which normally degrades LDL receptors in the liver. By inhibiting this protein, the drug allows the liver to remove more LDL from the blood. Unlike existing PCSK9 inhibitors that require injections, Lipfendra is taken as a daily pill on an empty stomach. Source: El Caribe

Efficacy and cost

Clinical trials showed LDL reductions of up to 60% after 24 weeks, bringing levels to as low as 50–60 mg/dL. Source: El Confidencial, Infobae The drug is priced at $315 for a 30-day supply, significantly less than injectable alternatives that cost $500–600 per month. Source: Infobae Merck hopes the oral form will increase access; currently only 1% of eligible patients use injectable PCSK9 inhibitors. Source: Infobae, El Confidencial

What remains unknown

While injectable PCSK9 inhibitors have been proven to reduce heart attacks and strokes by about 20%, similar outcome data for Lipfendra are not yet available. Merck is conducting a dedicated cardiovascular outcomes trial. Source: El Confidencial, Infobae The FDA approval was based on LDL reduction alone.