Merck Gains FDA Approval for New Oral Cholesterol-Lowering Medication

Merck has received FDA approval for Lipfendra, a daily oral medication that offers an alternative to statins for managing elevated LDL cholesterol, commonly referred to as “bad cholesterol.” The drug belongs to a class of medications known as PCSK9 inhibitors, which work by blocking a protein that prevents the liver from removing LDL from the bloodstream.

Statins have long been the primary treatment for high cholesterol, but they are associated with side effects such as muscle pain and may not sufficiently reduce LDL levels to meet clinical targets. Dr. Paja Banka, associate vice-president for global clinical development at Merck and a pediatric cardiologist, emphasized the significance of the approval, noting that 70% of patients fail to achieve recommended LDL goals with existing therapies.

“Lipfendra can be used alongside statins or as a standalone treatment,” Dr. Banka explained. Clinical trials indicated minimal side effects, with outcomes comparable to placebo, and no reports of muscle aches observed with statins.

Heart disease remains the leading cause of mortality in the U.S., with high LDL levels directly contributing to atherosclerotic cardiovascular disease (ASCVD). Per March 2023 guidelines from the American College of Cardiology and American Heart Association, LDL targets vary by risk level: under 100 mg/dL for borderline/intermediate risk, under 70 mg/dL for high risk, and under 55 mg/dL for very high-risk patients with existing ASCVD.

The New York Times reported that Lipfendra trials demonstrate LDL reductions to as low as 50–60 mg/dL. Historically, PCSK9 inhibitors required injections; the pill formulation is expected to enhance patient accessibility. Merck has priced the drug at $10.50 daily, though the company anticipates reduced out-of-pocket costs for many patients.

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