FDA Approves Merck's Enlicitide — A Daily Pill That Slashes Cholesterol Far Below Statin Levels

The FDA has approved enlicitide (brand name Lipfendra), a daily oral pill from Merck that can drive LDL cholesterol levels down to 50, 60, or even lower — well beneath what statins typically achieve. Adults not on any cholesterol medication generally carry LDL above 100, and new guidelines from the American Heart Association and American College of Cardiology set targets of below 70 for above-average-risk patients and below 55 for high-risk individuals, such as those who've already had a heart attack.

The drug works by inhibiting a protein called PCSK9, the same mechanism as existing injectable cholesterol drugs that carry list prices of $500 to $600 per month or more. Enlicitide's list price is set at $315 for a 30-day supply — meaningfully cheaper — and Merck says it will be available within weeks. The pill format addresses two major barriers that have kept injectable PCSK9 inhibitors from gaining traction: cost and needle aversion.

The adoption problem with existing PCSK9 inhibitors is stark. Despite roughly six million patients being eligible, only about 1 percent actually use the injectable versions, partly because insurers frequently resist covering them and partly because many patients simply don't want injections. That's a significant missed opportunity given that PCSK9 inhibitors can cut heart attack risk by 20 percent in high-risk patients.

Cardiologists unaffiliated with Merck praised both the FDA's decision and the drug's pricing, expressing hope that a more accessible pill form will finally bring effective cholesterol control to a much larger share of at-risk Americans. The approval comes as updated cardiovascular guidelines push for more aggressive LDL targets than were previously standard.