The US Food and Drug Administration (FDA) has approved Lipfendra (enlicitide), a once-daily cholesterol-lowering pill developed by Merck.
Event Context
The drug is the first oral medication in the PCSK9 inhibitor class, offering patients an alternative to injectable therapies that many have found expensive or inconvenient.
The approval comes as heart disease remains the leading cause of death globally. Physicians have long stressed the importance of lowering LDL, commonly known as “bad” cholesterol, especially among patients with a history of heart attack or stroke.
Player Focus
Dr Christopher Cannon, a cardiologist at Brigham and Women’s Hospital who was not involved in the drug’s development, told The New York Times he was “thrilled” by the approval, noting the lower cost compared with injectable PCSK9 therapies.
Injectable PCSK9 inhibitors have previously demonstrated a 20% reduction in heart attacks, strokes and cardiovascular deaths among 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 at elevated cardiovascular risk reduce LDL cholesterol below 70 mg/dL. Those at very high risk, including patients who have previously suffered heart attacks, should aim for below 55 mg/dL.
Team Analysis
Merck reported results from a 24-week Phase III trial involving 2,912 participants, showing LDL reductions comparable to injectable PCSK9 inhibitors. The company also said side effects were similar to those seen with placebo.
Merck Research Laboratories President Dr Dean Li said the company hopes primary care physicians, along with cardiologists, will also prescribe the medication.
Match Outlook
Cardiologists welcomed the FDA’s decision, saying an affordable oral alternative could dramatically expand access to advanced cholesterol treatment.
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Lipfendra, whose generic name is enlicitide, works by blocking a protein called PCSK9. The protein normally reduces the liver’s ability to remove LDL cholesterol from the bloodstream. By inhibiting PCSK9, the drug enables the liver to clear significantly more LDL cholesterol, helping patients achieve much lower cholesterol levels.
Clinical trials showed the pill reduced LDL cholesterol by up to 60%, bringing many patients’ levels down to 50-60 mg/dL or lower. Adults who are not taking cholesterol-lowering medication typically have LDL levels above 100 mg/dL.
The approval is particularly notable because existing PCSK9 inhibitors are available only as injections. While these drugs have been highly effective, their cost and injectable format have limited their use.
According to Merck, Lipfendra will carry a list price of $315 for a 30-day supply, considerably below the list prices of injectable PCSK9 drugs, which generally range between $500 and $600 per month.
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