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The FDA has given the green light to a new daily oral medication for millions of Americans struggling with high cholesterol. Merck, the pharmaceutical company behind Lipfendra (enlicitide), announced the approval this past Thursday.
Lipfendra works by blocking PCSK9, a protein in the liver that interferes with the body’s ability to clear LDL cholesterol-the so-called “bad” cholesterol-from the bloodstream. According to Dr.
Marc Siegel, senior medical analyst at Fox News, PCSK9 prevents the recycling of LDL receptors, which leads to higher cholesterol levels. While this mechanism may have been helpful during our hunter-gatherer days, today it contributes significantly to the buildup of plaques that cause heart disease.
The newly approved pill is intended as an addition to diet and other cholesterol-lowering treatments for adults with high cholesterol, including those with inherited forms. In clinical trials, Lipfendra showed impressive results, reducing LDL cholesterol by approximately 56% to 60% when used alongside statins-roughly double the impact of statins alone.
Merck reports that the medication was generally well-tolerated in trials, with the most common side effects being mild, such as diarrhea and dizziness. Serious adverse effects were rare and occurred at rates similar to those seen with placebo.
Statins remain the most widely prescribed drugs for lowering cholesterol by inhibiting a liver enzyme involved in cholesterol production. For many patients, statins suffice. However, those with extremely high cholesterol, genetic conditions, or intolerance to statins may benefit from additional therapies like PCSK9 inhibitors.
Until now, PCSK9 inhibitors such as Repatha and Praluent have been available only as injections, which some experts believe limited their use. Lipfendra’s oral formulation offers a convenient alternative that is both effective and well-tolerated, Siegel noted.
While Lipfendra’s cholesterol-lowering effects are clear, further studies are underway to determine if it also reduces the risk of heart attacks, strokes, and cardiovascular deaths. Merck expects results from a large clinical trial by 2029.
“Lowering LDL cholesterol as much as possible is crucial for those at risk of heart disease,” said Siegel, echoing insights from Dr. Steve Nissen, a leading figure in preventive cardiology.
This new oral PCSK9 inhibitor represents a promising advancement in the fight against heart disease, offering an additional option for patients aiming to better manage their cholesterol levels.