The U.S. Food and Drug Administration has approved a new daily pill that could help millions of patients who struggle to lower their bad cholesterol, even when taking statins. Drugmaker Merck announced the approval of Lipfendra, a powerful new option for managing high LDL cholesterol, on Thursday. The medication offers a long-awaited alternative for the roughly 70 percent of patients who do not reach their target cholesterol levels with statins alone.
For decades, statins have been the standard treatment for high cholesterol and remain the most prescribed class of medication in the United States. However, some patients experience side effects such as muscle aches, while others simply do not see enough of a drop in their LDL levels. Lipfendra belongs to a class of drugs known as PCSK9 inhibitors, which work by helping the liver remove more LDL cholesterol from the blood. Unlike older versions of these drugs, which required injections, this new pill can be taken by mouth once a day. Dr. Paja Banka, a pediatric cardiologist and associate vice president at Merck, said the drug can be used “in conjunction” with statins or, in some cases, on its own. She noted that side effects in clinical trials were minimal and “like the placebo,” with no reports of the muscle aches sometimes linked to statins.
Heart disease remains the leading cause of death in the United States, and high LDL cholesterol is a key driver of atherosclerotic cardiovascular disease, or plaque buildup in the arteries. According to updated guidelines from the American College of Cardiology and the American Heart Association, LDL levels should generally stay below 100 mg/dL. For patients at high risk, the target is below 70 mg/dL, and for those with existing cardiovascular disease, the goal is below 55 mg/dL. Clinical trials have shown that Lipfendra can bring LDL levels “down to 50 or 60 or even lower,” according to reports. The shift from an injectable to a pill form is expected to make the therapy far more accessible and convenient for patients.
Merck has set the list price for Lipfendra at $10.50 per day, or about $315 per month. The company says many patients will likely pay less out of pocket depending on insurance coverage. With heart disease claiming more lives than any other condition in the U.S., the arrival of a well-tolerated, oral PCSK9 inhibitor offers a hopeful new tool for preventing first heart attacks and strokes, especially for those who have not been able to reach their cholesterol goals with existing treatments.