FDA approves Merck cholesterol pill, lower-cost option

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1–2 minutes

Summary

FDA approved Merck’s daily cholesterol pill, which lowered LDL by up to 60% in trials and will be priced below similar injectable drugs.

Why this matters

The approval adds a lower-cost, non-injectable option for patients who need to reduce LDL cholesterol beyond what statins typically achieve. Its price and convenience could affect access and treatment decisions for millions of eligible patients.

The Food and Drug Administration on Thursday approved enlicitide, a daily cholesterol-lowering pill from Merck that works by inhibiting a protein known as PCSK9.

Merck said the drug, sold under the brand name Lipfendra, will have a list price of $315 for a 30-day supply and will be available in a few weeks.

Clinical trials showed the drug lowered low-density lipoprotein, or LDL, cholesterol by up to 60%, according to Merck. Adults not taking cholesterol-lowering drugs usually have LDL levels above 100. New guidelines from the American Heart Association and American College of Cardiology say people with above-average risk of heart attack or stroke should get LDL below 70, while those at high risk, including people who have had a heart attack, should get it below 55.

In November, Merck reported results from a 24-week trial involving 2,912 people. The company said there was no difference in side effects between Lipfendra and a placebo.

Injectable drugs that target PCSK9 are already on the market, with list prices of $500 to $600 a month or more. Insurers sometimes do not cover them, and some patients do not want injections. Only 1% of the 6 million eligible patients use the injected drugs.

Studies of injectable PCSK9 drugs found they reduced heart attacks, strokes, and cardiovascular deaths by 20% in high-risk patients. Merck is conducting a study to determine whether Lipfendra has the same effect.

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