Merck says FDA approves oral PCSK9 inhibitor Lipfendra for adults with high LDL-C

Merck & Co., Inc.

Merck & Co., Inc.

MRK

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  • Merck won FDA clearance for LIPFENDRA (enlicitide), a once-daily oral PCSK9 inhibitor to cut LDL-C in adults with hypercholesterolemia.
  • Phase 3 CORALreef Lipids and CORALreef HeFH data showed placebo-adjusted LDL-C reductions of 56% and 59% at week 24.
  • A cardiovascular outcomes trial is ongoing; an effect on cardiovascular morbidity or mortality remains unproven.


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