FDA Approves Merck's $315 Lipfendra Pill, Cutting LDL Cholesterol by Up to 60%

3 articles · Updated · Scientific American · Jul 16

Enlicitide, to be sold as Lipfendra, won FDA approval as a once-daily cholesterol pill that can lower LDL to about 50 or below in many patients.
Clinical trials showed the drug cut LDL by up to 60% over roughly six months in adults with, or at risk of, atherosclerotic cardiovascular disease, with side effects comparable to placebo.
Lipfendra works by blocking PCSK9, the same pathway targeted by injectable drugs that have been available for about a decade but cost far more than its $315 list price for a 30-day supply.
The approval lands after March cholesterol guidelines urged LDL below 70 for at-risk patients and below 55 for high-risk patients; Merck is still testing whether the pill prevents heart attacks and strokes.

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The New York Times1d ago

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11 Sources

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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.

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