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FDA OKs Merck's Oral PCSK9 Pill, Cuts LDL 56%

7/16/2026

Summary

Merck FDA-Approval

FDA approved Merck’s oral PCSK9 inhibitor enlicitide (Lipfendra) on July 16, 2026.
In two late-stage trials of 3,207 adults on maximal statins, Lipfendra lowered LDL cholesterol by 56% from 96 mg/dL and 59% from 119 mg/dL after 24 weeks.
The pill costs $315 for a 30-day supply versus $500-$600 monthly for injectables, prompting a 4% rise in Merck’s shares and projected $5 billion peak annual sales by 2034.

Summary

Merck Gains Clearance

The cardiovascular outcomes trial for Lipfendra will report in 2029, assessing heart attacks, strokes and cardiovascular deaths.
Merck reports side-effects resemble placebo, with mild diarrhea and dizziness, and that the FDA cleared the oral pill as add-on to diet and LDL-lowering therapies.
ACC/AHA guidelines issued in March recommend LDL below 100 mg/dL, a target the pill aims to meet and could boost use amid low uptake of injectable PCSK9 inhibitors.

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Merck FDA-Approval

FDA approved Merck’s oral PCSK9 inhibitor enlicitide (Lipfendra) on July 16, 2026.
In two late-stage trials of 3,207 adults on maximal statins, Lipfendra lowered LDL cholesterol by 56% from 96 mg/dL and 59% from 119 mg/dL after 24 weeks.
The pill costs $315 for a 30-day supply versus $500-$600 monthly for injectables, prompting a 4% rise in Merck’s shares and projected $5 billion peak annual sales by 2034.

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