FDA Approves Merck's $315 Cholesterol Pill, Targeting LDL Below 70
Updated
Updated · The New York Times · Jul 16
FDA Approves Merck's $315 Cholesterol Pill, Targeting LDL Below 70
2 articles · Updated · The New York Times · Jul 16
Summary
Thursday's approval clears Merck's daily pill enlicitide, sold as Lipfendra, to lower LDL cholesterol far beyond typical statin results.
Clinical trials showed LDL can fall to 50 or 60 or lower, versus above 100 in adults not taking cholesterol drugs; the pill works by blocking the PCSK9 protein.
Merck set a list price of $315 for a 30-day supply, with launch expected in a few weeks—below injectable PCSK9 drugs that often cost $500 to $600 a month or more.
Only 1% of roughly 6 million eligible patients use those injectables, partly because insurers resist coverage and some patients avoid shots, even though the drug class cuts heart-attack risk by 20% in high-risk patients.
New U.S. heart guidelines call for LDL below 70 for above-average-risk patients and below 55 for high-risk patients, a target cardiologists say the easier-to-take pill could help more people reach.
With a new $315 monthly pill, will millions finally control their cholesterol, or is it still too costly?
As Merck’s oral pill challenges injectables, is this the end for billion-dollar cholesterol shots?
Beyond pills and injections, could a new DNA therapy soon make all current cholesterol drugs obsolete?
Lipfendra (Enlicitide) FDA-Approved: First Oral PCSK9 Inhibitor Achieves 60% LDL-C Reduction in Hypercholesterolemia
Overview
The FDA approved Merck’s Lipfendra (enlicitide) on July 16, 2026, marking a major step forward in hypercholesterolemia treatment. Lipfendra is the first once-daily oral PCSK9 inhibitor, offering a convenient alternative to injectable therapies. Its approval was based on strong results from Phase 3 trials, where it achieved over 50% reduction in LDL cholesterol and also lowered other harmful lipoproteins. Lipfendra works by blocking PCSK9, which increases the number of LDL receptors on liver cells and helps clear cholesterol from the blood. The drug showed a favorable safety profile, making it a promising new option for patients.