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.