Overview
- The FDA granted approval on Thursday, July 16, 2026, for Lipfendra (enlicitide) as an add-on treatment for adults with hypercholesterolemia, including familial forms.
- Two Phase 3 trials showed Lipfendra lowered LDL cholesterol by about 56%–60% at 24 weeks and was generally well tolerated, with the most common side effects being diarrhea and dizziness.
- Merck will sell Lipfendra as a once-daily 20 mg tablet at a list price of about $10.50 per day (roughly $315 per month) and expects it to reach pharmacies within weeks, including availability through TrumpRx.gov.
- The FDA used the Commissioner's National Priority Voucher expedited review to clear the drug, a fast track that has supporters for speed and critics who call for reform of the program.
- The approval strengthens Merck's commercial portfolio as Keytruda faces upcoming patent pressures, analysts project multibillion-dollar peak sales for Lipfendra, and a large outcomes study due in 2029 will determine whether the LDL drops translate into fewer heart attacks and strokes.