What do we know about new cholesterol drug Lipfendra? Merck’s new once-daily drug gets FDA approval
The U.S. Food and Drug Administration (FDA) has approved Lipfendra (enlicitide), a once-daily cholesterol-lowering drug developed by Merck & Co.
The drug is the first oral drug in the PCSK9 inhibitor class and offers patients an alternative to injectable treatments, which many find expensive or inconvenient.
The approval comes as heart disease remains the leading cause of death worldwide. Doctors have long stressed the importance of lowering LDL, commonly known as “bad” cholesterol, especially in patients with a history of heart disease or stroke.
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What is Lipfendra and how does it work?
Lipfendra, whose generic name is enlicitide, works by blocking a protein called PCSK9. This protein typically reduces the liver’s ability to remove LDL cholesterol from the blood. By inhibiting PCSK9, the drug enables the liver to clear more LDL cholesterol, helping patients achieve lower cholesterol levels.
Clinical trials have shown that the drug can lower LDL cholesterol by up to 60%, reducing levels to 50-60 mg/dL or less in many patients. Adults who are not taking cholesterol-lowering drugs usually have LDL levels above 100 mg/dL.
The approval is particularly notable because existing PCSK9 inhibitors are only available in injectable form. Although these drugs are highly effective, their cost and injectable form limit their use.
According to Merck, Lipfendra is priced at $315 for a 30-day supply, well below the list price of the injectable PCSK9 drug, which typically costs $500 to $600 per month.
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Why would approval be a game changer?
Cardiologists welcomed the FDA’s decision, saying an affordable oral alternative could greatly expand access to advanced cholesterol treatments.
Dr. Christopher Cannon, a cardiologist at Brigham and Women’s Hospital who was not involved in the development of the drug, told The New York Times that he was “excited” about the approval, noting the lower cost compared with injectable PCSK9 therapies.
Injectable PCSK9 inhibitors have previously been shown to reduce the risk of heart attack, stroke and cardiovascular death by 20% in high-risk patients. Merck is conducting a separate cardiovascular outcomes study to determine whether Lipfendra provides the same protection.
Current guidelines from the American Heart Association (AHA) and the American College of Cardiology (ACC) recommend that patients with higher cardiovascular risk should lower their LDL cholesterol to less than 70 mg/dL. Those at very high risk, including those with previous heart disease, should aim for a concentration below 55 mg/dL.
Merck reported results from a 24-week Phase III trial involving 2,912 participants, showing LDL reductions comparable to those of an injectable PCSK9 inhibitor. The company also said side effects were similar to placebo.
Dr. Dean Li, president of Merck Research Laboratories, said the company hopes primary care physicians and cardiologists will also prescribe the drug.
