Merck says FDA approves oral PCSK9 inhibitor Lipfendra for adults with high LDL-C
MRK•FDA approves Merck's Lipfendra
Merck says the FDA has cleared LIPFENDRA (enlicitide), a once-daily oral PCSK9 inhibitor to cut LDL-C in adults with hypercholesterolemia.
- 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.
Outcomes study remains ongoing
A cardiovascular outcomes trial is ongoing; an effect on cardiovascular morbidity or mortality remains unproven.
