Drugmaker Merck announces approval of new cholesterol-fighting drug | US news

Pharmaceutical giant Merck announced Thursday that it has received FDA approval for a daily pill that could be an alternative to statins to treat high LDL levels, or bad cholesterol. The new pill Lipfendra is a version of the drug called the PCSK9 inhibitor.

For decades, the go-to treatment for high cholesterol levels has been statins, the most prescribed drug in the United States. But statins can occasionally cause side effects, such as muscle aches, and sometimes they don’t lower cholesterol levels enough to reach recommended levels.

Merck vice president of global clinical development and pediatric cardiologist Dr. Puja Banka said this development was important because statins do not have enough effect to reduce LDL levels to recommended levels.

“Seventy percent of patients fail to reach the LDL goal,” he said.

The new pill is to be taken “in conjunction” with statins, but can be taken alone in some cases, he said. He said that the side effects of the newly approved drug appeared to be minimal in the trials, and no muscle pain was experienced. He said the side effects were “like a placebo.”

Merck said the new drug should be ready within weeks.

Heart disease is the leading cause of death in the United States, and high LDL levels are known to cause atherosclerotic cardiovascular disease (ASCVD), or plaque buildup.

Acceptable LDL cholesterol levels vary depending on a patient’s history and risk, but the American College of Cardiology and the American Heart Association recommend that levels should always be below 100, according to new guidelines published in March.

According to the guidelines, “To prevent a first heart attack or stroke, the LDL-C target 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 for ASCVD events, the LDL-C target for secondary prevention of cardiac events should be less than 55 mg/dL.”

The New York Times reported that clinical trials showed Merck’s new drug could lower LDL “to 50 or 60, or even lower.”

Previously this medicine had to be taken by injection. A pill is expected to make its use more widespread.

Merck says the drug’s list price will be $10.50 per day, or more than $300 per month, but expects out-of-pocket costs to be lower for many patients.