The FDA approved Merck’s oral PCSK9 cholesterol drug, enlicitide (branded Lipfendra), marking the first US approval for an oral PCSK9 pill. The approval comes after clinical data showing LDL reductions that can run substantially below levels typically achieved with statins. Regulators also weighed a guideline shift earlier in the year: the American Heart Association and American College of Cardiology issued updated cholesterol targets in March. Merck is also running studies to evaluate whether the therapy can reduce heart attacks and strokes, with the oral formulation positioned as a potential adherence advantage over injections. Competitively, Merck has also been racing AstraZeneca for market timing in oral PCSK9 therapy, with the clearance strengthening Merck’s leadership in lipid management innovation.