FDA Approves Merck’s Daily Cholesterol Pill Lipfendra After 56%-60% LDL Cuts

3 articles · Updated · Fox News · Jul 16

Merck’s Lipfendra became the first once-daily oral PCSK9 inhibitor cleared by the FDA for adults with high cholesterol as an add-on to diet and other LDL-lowering therapies.
Phase 3 trials showed the pill cut LDL cholesterol by about 56% to 60% when combined with statins, targeting patients whose cholesterol remains high or who have inherited forms of the disease.
Diarrhea and dizziness were the most common side effects, while serious adverse events and treatment discontinuations were similar to placebo, according to Merck.
PCSK9 drugs such as Repatha and Praluent had previously been available only as injections, a limitation experts say contributed to underuse despite strong LDL-lowering effects.
A large outcomes trial due in 2029 will test whether Lipfendra’s LDL reductions also translate into fewer heart attacks, strokes and cardiovascular deaths.

Sources

Fox News1h ago

FDA Approves Merck's Oral PCSK9 Inhibitor Lipfendra for High Cholesterol

The New York Times4h ago

FDA Approves Merck's Enlicitide Pill to Significantly Lower Cholesterol

Reuters4h ago

Merck's cholesterol pill gets US FDA approval | Reuters

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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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