Merck’s cholesterol pill could challenge injectables

Merck’s oral drug enlicitide lowered “bad” cholesterol (LDL-C) by up to 59% in Phase 3 trials, matching results seen with injectable PCSK9 inhibitors from Amgen and Regeneron.

Why it matters: If approved, enlicitide could become the first oral PCSK9 drug, offering a more convenient, potentially lower-cost option to millions needing aggressive cholesterol control, without injections.

Backstory: Injectable PCSK9 inhibitors like Repatha and Praluent have proven effective but face hurdles due to cost, storage needs, and patient reluctance around injections. Enlicitide targets the same PCSK9 protein but in pill form, and has shown similar efficacy in lowering LDL-C in two key trials.

Zoom in: In a 2,900-person trial, enlicitide cut LDL-C by 56% in 6 months and maintained a 48% drop at 12 months. This success was even greater in a genetic high-cholesterol group that achieved a 61.5% LDL-C reduction over one year.

Big picture: This pill could shake up the cholesterol treatment market, boosting access, improving adherence, and putting pressure on pricing.

Yes, but: For broader approval, Merck still needs to prove that enlicitide can also reduce heart attacks and strokes. Concerns also remain regarding adherence to the treatment, as fasting is required from patients before and after taking the pill for maximum efficacy.