Merck won US FDA approval for Lipfendra (enlicitide), marking the first US clearance for an oral PCSK9 cholesterol-lowering drug. The approval comes as Merck’s oral alternative targets PCSK9 to drive LDL reductions beyond what statins can typically achieve. Clinical trial data cited around FDA’s decision show LDL reductions potentially reaching the 50 mg/dL range or lower, with side effects described as comparable to placebo. The product is positioned for once-daily dosing and is expected to launch at $315 for a 30-day supply. A core competitive implication is that the new pill could expand access for patients who prefer oral therapy over injectable PCSK9 inhibitors—potentially changing prescribing patterns in high-risk hypercholesterolemia and cardiovascular prevention.