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FDA approves Merck's LIPFENDRA, first oral PCSK9 inhibitor to lower LDL cholesterol.

Market News
16 Jul 2026
Benzinga
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Bullish
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The FDA has approved Merck's LIPFENDRA (enlicitide), the first oral PCSK9 inhibitor designed to reduce LDL cholesterol in adults with hypercholesterolemia, including those with heterozygous familial hypercholesterolemia (HeFH). This once-daily pill showed significant LDL-C reductions in two Phase 3 trials, with up to 60% decrease compared to placebo. Merck is continuing trials to determine if LIPFENDRA can reduce cardiovascular events and mortality. The approval adds a new treatment option for managing high cholesterol, a major risk factor for cardiovascular disease.

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