FDA Clears First Cholesterol Pill To Rival Costly Injections

Key TakeawaysThe U.S. Food and Drug Administration approved Lipfendra, the first pill that blocks a cholesterol-raising protein called PCSK9Daily tablet list price is $315 a month, far less than injectable versions at $500 to $600Bad cholesterol fell 56% to 59% after 24 weeks in two trials of 3,207 adults.THURSDAY, July 16, 2026 (HealthDay News) — A new daily pill will give people with stubbornly high cholesterol a cheaper, needle-free way to drive their levels down.The U.S. Food and Drug Administration (FDA) acted today to approve Lipfendra (enlicitide), the first drug taken by mouth that blocks a protein called PCSK9 that limits how much "bad" LDL cholesterol the body clears from the blood.Injectable PCSK9 inhibitors have been on the market for years, but list prices run $500 to $600 a month or more and some patients don't want shots, reports The New York Times.Lipfendra will list at $315 for a 30-day supply and should reach pharmacies within a few weeks, Merck spokesperson Julie Cunningham told The Times.The FDA approved the once-daily tablet for use with diet and exercise in adults with high cholesterol and in those with heterozygous familial hypercholesterolemia (HeFH), an inherited form of the condition.Two trials involving 3,207 adults already taking the highest statin dose they could tolerate drove the approval, the FDA said.In the first study, which enrolled people who had atherosclerotic cardiovascular disease (ASCVD) or were at high risk for it, average LDL fell 56% from a baseline of 96 mg/dL after 24 weeks, compared with placebo. In the second study, limited to adults with inherited HeFH, LDL dropped 59% from an average of 119 mg/dL.ASCVD is when plaque builds up in the blood vessels that lead to the heart, of which cholesterol plays a major role.Side effects occurred about as often with the drug as with placebo in the first trial, according to the FDA. In the HeFH trial, diarrhea and dizziness were more common with Lipfendra. Similar proportions of patients in both groups stopped treatment due to side effects.Injected PCSK9 inhibitors cut heart attacks, strokes and cardiovascular deaths by 20% in high-risk patients, according to The Times. Merck is running a trial to see whether Lipfendra does the same.Cardiologists welcomed the approval."I'm thrilled," Dr. Christopher Cannon, a cardiologist at Brigham and Women's Hospital in Boston, told The Times. He consults for several drug makers but not Merck."This would make a big difference compared with the cost of injectable PCSK9 inhibitors," said Dr. David Maron, a preventive cardiologist at Stanford University in California.Merck wants lowering cholesterol with the drug to feel as routine as taking a statin, and primary care doctors, not just cardiologists, can prescribe it, Dr. Dean Li, president of Merck Research Laboratories, told The Times.New guidelines from the American Heart Association and the American College of Cardiology urge people at above-average risk for heart attack or stroke to get LDL below 70, and those at high risk, such as heart attack survivors, below 55.More informationVisit the U.S. Centers for Disease Control and Prevention for more information about lowering cholesterol.SOURCES: The New York Times, July 16, 2026; U.S. Food and Drug Administration, July 16, 2026 .What This Means For YouIf your cholesterol levels are still high despite a statin, ask your doctor whether this pill is worth trying..Sign up for our weekly HealthDay newsletter

FDA Clears First Cholesterol Pill To Rival Costly Injections

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