Overview
- The FDA granted approval in mid‑July for Lipfendra (enlicitide) as an add‑on to diet and exercise for adults with high LDL cholesterol, including those with heterozygous familial hypercholesterolemia.
- Two Phase III randomized trials of 3,207 adults on maximally tolerated statins showed mean LDL‑C reductions of about 56% and 59% at 24 weeks versus placebo when Lipfendra was added.
- Lipfendra is taken once daily by mouth and works by inhibiting the PCSK9 protein so the liver clears more LDL from the blood, providing a non‑injectable alternative to existing PCSK9 therapies.
- Short‑term safety in the trials was acceptable with the most reported side effects being diarrhea and dizziness and discontinuation rates similar to placebo, but a large Merck cardiovascular outcomes trial is still underway to measure effects on heart attacks and strokes.
- Real‑world uptake will hinge on cost, insurer prior‑authorization rules and patient adherence, and clinicians say statins will remain first‑line treatment with Lipfendra aimed at patients who need further LDL reduction.