A new once-daily cholesterol pill has received approval from the U.S. Food and Drug Administration, opening a fresh option for millions of Americans dealing with high LDL levels.

Merck, based in New Jersey, announced that the agency has cleared its oral PCSK9 inhibitor, Lipfendra (enlicitide), for use as an add-on to diet and other LDL-lowering therapies in adults with high cholesterol, including inherited conditions.

The medication works by blocking PCSK9, a naturally occurring protein that influences how the liver removes LDL, or “bad” cholesterol, from the bloodstream.

Fox News senior medical analyst Dr. Marc Siegel explained that PCSK9 prevents the recycling of LDL receptors in the liver, which increases cholesterol levels. "In the caveman days, this was useful when we were hunter-gatherers and didn't always have food, but now it mainly forms plaques that lead directly to heart disease," he said.

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Clinical data suggest the pill could reshape cholesterol management. In phase 3 trials, Lipfendra reduced LDL cholesterol by approximately 56 to 60 percent when paired with statins.

"This is around double the impact of statins," Siegel noted, describing the results as significant.

Merck reported that the pill was generally well-tolerated during testing. The most common side effects included diarrhea and dizziness, with serious adverse events and discontinuation rates similar to those seen in the placebo group.

The approval marks a major milestone for patients who struggle to achieve cholesterol targets using statins alone. Statins remain the most widely prescribed cholesterol-lowering drugs, according to the American Heart Association, because they reduce cholesterol production in the liver.

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However, some patients with high or inherited cholesterol levels, or those who cannot tolerate statins, may require an additional treatment. PCSK9 inhibitors have long filled that role, but until now, all were injected rather than taken orally.

Existing PCSK9 inhibitors, such as Repatha and Praluent, have proven effective but are delivered by injection. Experts believe that mode of administration has discouraged widespread use.

"Repatha, the injectable form, is very useful, with few side effects," Siegel said. "The oral form, Lipfendra, is also well-tolerated and just as effective."

Merck said additional research will determine whether Lipfendra reduces the risk of heart attacks, strokes, and cardiovascular deaths. A large outcomes trial is underway, with results expected in 2029.

Dr. Steve Nissen, longtime head of preventive cardiology at Cleveland Clinic, told Siegel that lower cholesterol is always better for those at risk of heart disease.

For now, the FDA’s approval of Lipfendra introduces the first oral option in a powerful drug class that until recently required injections, signaling a notable advancement in cardiovascular medicine.