FDA Approves First Oral PCSK9 Inhibitor for High Cholesterol

The U.S. FDA has granted approval for Merck's Lipfendra (enlicitide), marking a significant advancement as the first oral PCSK9 inhibitor. This medication is intended to complement diet and exercise in reducing LDL cholesterol levels for adults with hypercholesterolemia, including those with heterozygous familial hypercholesterolemia. Clinical trials demonstrated its effectiveness in lowering LDL by a substantial margin, comparable to existing injectable treatments, and it will be offered at a more accessible price point.