FDA Approves Merck Daily Pill for High LDL Cholesterol

The Guardian reported that Merck announced Thursday it had received FDA approval for Lipfendra, a daily pill version of a PCSK9 inhibitor for treating high LDL cholesterol. Lipfendra is intended as an alternative to statins, the most prescribed medication in the US for high cholesterol.

Statins can cause side effects such as muscle aches and sometimes fail to lower cholesterol to recommended levels.

Dr. Paja Banka, associate vice-president for global clinical development at Merck and a pediatric cardiologist, stated that 70% of patients are not reaching their LDL goal with statins. She said the new pill would be taken in conjunction with statins, though in some cases it could be taken alone.

Side effects of Lipfendra appeared minimal in trials, with no muscle aches, and were like the placebo, she added. Merck stated the new drug should be ready within weeks. Heart disease is the leading cause of death in the US, and high LDL levels are known to cause atherosclerotic cardiovascular disease, or plaque buildup.

Guidelines issued in March by the American College of Cardiology and the American Heart Association recommend LDL cholesterol levels should always be below 100 mg/dL. To prevent a first heart attack or stroke, the LDL-C goal should be less than 100 mg/dL for those at borderline or intermediate risk and less than 70 mg/dL for those at high risk.

For individuals with ASCVD who are at very high risk of ASCVD events, the LDL-C goal should be less than 55 mg/dL for secondary prevention of cardiac events.

Clinical trials show Merck’s new drug can bring LDL down to 50 or 60 mg/dL or even lower. Previously this medication had to be taken as an injection. Merck stated the drug’s list price will be $10.50 a day, or more than $300 a month, though it expects out-of-pocket costs to be lower for many patients.