Merck announced on Thursday that the US Food and Drug Administration (FDA) has approved its new daily pill, Lipfendra, designed to lower high levels of LDL cholesterol, often referred to as 'bad' cholesterol. The drug is a version of a PCSK9 inhibitor and can serve as an alternative or complement to statins, the most prescribed medication in the United States.
Limitations of Statins
Statins have been the go-to therapy for high cholesterol for decades, but they come with drawbacks. Some patients experience side effects such as muscle aches, and in many cases, statins do not reduce cholesterol levels enough to meet recommended targets. Dr Paja Banka, associate vice-president for global clinical development at Merck and a pediatric cardiologist, highlighted the significance of the new drug. 'Seventy per cent of patients are not getting to their LDL goal,' she said.
How Lipfendra Works
Lipfendra is a PCSK9 inhibitor, a class of drugs that helps the liver remove more LDL cholesterol from the blood. Previously, such medications were only available as injections. The pill form is expected to make the treatment more accessible and widely used. Dr Banka noted that the drug would typically be taken 'in conjunction' with statins, but in some cases, it could be used alone. Side effects in clinical trials were minimal, with no reports of muscle aches; she described them as 'like the placebo'.
Impact on Heart Disease
Heart disease is the leading cause of death in the US, and high LDL levels are known to contribute to atherosclerotic cardiovascular disease (ASCVD), or plaque buildup in arteries. According to new guidelines issued in March by the American College of Cardiology and the American Heart Association, LDL cholesterol levels should always be below 100 mg/dL. For those at borderline or intermediate risk, the goal is less than 100 mg/dL; for high-risk individuals, less than 70 mg/dL; and for those with ASCVD at very high risk, the target is below 55 mg/dL to prevent secondary cardiac events.
Clinical Trial Results
Clinical trials have shown that Lipfendra can dramatically lower LDL levels. The New York Times reported that the drug can reduce LDL 'down to 50 or 60 or even lower'. Merck stated that the drug should be available within weeks.
Pricing and Availability
Merck has set the list price at $10.50 per day, which amounts to over $300 per month. However, the company expects out-of-pocket costs to be lower for many patients through insurance and other discounts.
