FDA Clears First Cholesterol Pill, Lipfendra, To Rival Costly Injections

By Ellyn Vohnoutka HealthDay Reporter

Medically reviewed by Carmen Pope, Senior Medical Editor, B. Pharm. Last updated on July 16, 2026.

THURSDAY, July 16, 2026 — 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.

Sources

The New York Times, July 16, 2026
U.S. Food and Drug Administration, July 16, 2026

Disclaimer: Statistical data in medical articles provide general trends and do not pertain to individuals. Individual factors can vary greatly. Always seek personalized medical advice for individual healthcare decisions.