New Cholesterol Drug Approved by FDA
Millions of Americans struggling with high cholesterol now have a new option for treatment. The FDA has recently approved Lipfendra, a medication that can be taken once daily and is categorized as a PCSK9 inhibitor.
Merck, the company based in New Jersey that produces Lipfendra, announced the approval this past Thursday. This medication works by blocking PCSK9, a protein that impacts how the liver processes LDL cholesterol, often referred to as “bad” cholesterol.
Dr. Marc Siegel, a medical expert, explains that PCSK9 prevents the recycling of LDL receptors in the liver, which leads to higher levels of bad cholesterol in the blood. He notes that this protein was helpful in the past when humans had inconsistent food supplies, but today it often contributes to plaque buildup, which is a major cause of heart disease.
According to Merck, Lipfendra is intended for adults with high cholesterol who are already adjusting their diets and using other therapies to lower LDL levels, including those with genetic high cholesterol. In clinical trials, the medication was shown to reduce LDL cholesterol by about 56% to 60% when used alongside statins, marking a significant increase compared to statin use alone.
Lipfendra was generally well-tolerated in these trials. The most common side effects reported were diarrhea and dizziness, while serious side effects were similar to those experienced by participants taking a placebo.
Statins remain the most frequently prescribed drugs for lowering cholesterol. They work by blocking an enzyme the liver needs to produce cholesterol. For many, statins are effective on their own, but they might not work for everyone, especially those with very high cholesterol or those who cannot tolerate statins.
Previously, PCSK9 inhibitors have only been available via injections, which may have limited their use. Experts believe that Lipfendra’s oral format may encourage more people to use it. Dr. Siegel highlighted that both forms—injectable and oral—are effective and have minimal side effects.
Merck plans to conduct further research to determine Lipfendra’s impact on heart attacks, strokes, and cardiovascular deaths, with results from a significant clinical trial expected by 2029.
In the meantime, health professionals emphasize that maintaining low LDL cholesterol levels is crucial for individuals at risk of heart disease.
