MERCK RECEIVES FDA APPROVAL FOR CHOLESTEROL PILL LIPFENDRA

Merck announced Thursday that it had received approval from the Food and Drug Administration for Lipfendra, a daily pill designed to treat high LDL cholesterol levels. The drug is a PCSK9 inhibitor and can be taken alongside statins or as an alternative to them. Merck stated the medication would be available within weeks. Dr Paja Banka, associate vice-president for global clinical development at Merck, said the drug addresses limitations of existing treatments.

Statins remain the most commonly prescribed medication in the United States for managing high cholesterol, though they occasionally produce side effects including muscle aches and do not always reduce cholesterol to recommended levels. According to Dr Banka, approximately 70 per cent of patients do not reach their LDL goals with statins alone. Clinical trials of Lipfendra indicated minimal side effects, with none of the muscle aches associated with statins; reported side effects matched those of placebo. The American College of Cardiology and American Heart Association issued guidelines in March recommending that LDL cholesterol levels remain below 100 mg/dL for those at borderline or intermediate risk, and below 70 mg/dL for those at high risk.

Heart disease ranks as the leading cause of death in the United States, with high LDL levels recognised as a factor in atherosclerotic cardiovascular disease. Clinical trial data suggested Lipfendra could reduce LDL levels to between 50 and 60 mg/dL or lower. Previously, this class of medication required injection rather than oral administration. The approval expands treatment options for patients whose cholesterol levels remain elevated despite statin use.