Merck’s Lipfendra, the first oral PCSK9 inhibitor, has received FDA approval, demonstrating a significant reduction in LDL cholesterol levels for millions of Americans with high cholesterol.
Millions of Americans with high cholesterol now have a new treatment option following the FDA’s approval of Lipfendra, the first once-daily oral PCSK9 inhibitor. Merck, the New Jersey-based manufacturer of Lipfendra (enlicitide), announced the approval on Thursday.
Lipfendra works by blocking the action of PCSK9, a naturally occurring protein that plays a crucial role in how the liver removes LDL, commonly referred to as “bad” cholesterol, from the bloodstream. According to Dr. Marc Siegel, Fox News senior medical analyst, “PCSK-9 is a protein that works in the liver, preventing the recycling of LDL receptors, which results in increased bad cholesterol in the blood.” He noted that while this mechanism may have been beneficial in the past for hunter-gatherers, it now contributes to the formation of plaques that lead directly to heart disease.
The FDA has approved Lipfendra as an add-on treatment to diet and other LDL-lowering therapies for adults with high cholesterol, including those with inherited forms of the condition. In phase 3 clinical trials, Lipfendra demonstrated an impressive reduction in LDL cholesterol levels, achieving a decrease of approximately 56% to 60% when used in conjunction with statin therapy.
<p”This is around double the impact of statins,” Siegel remarked, highlighting the potential of Lipfendra to significantly enhance cholesterol management for patients.
Merck reported that the pill was generally well-tolerated during clinical trials, with the most common side effects being diarrhea and dizziness. Serious side effects and treatment discontinuations occurred at rates comparable to those in the placebo group.
Statins, which work by blocking an enzyme in the liver responsible for cholesterol production, are the most commonly prescribed medications for lowering cholesterol, according to the American Heart Association. While statins are effective for many individuals, some patients with very high cholesterol levels, inherited forms of high cholesterol, or those who experience adverse side effects from statins may require additional treatment options, such as a PCSK9 inhibitor like Lipfendra.
Previously, PCSK9 inhibitors such as Repatha and Praluent were only available as injections, a factor that experts believe may have contributed to their underuse. “Repatha, the injectable form, is very useful, with few side effects,” Siegel noted. “The oral form, Lipfendra, is also well-tolerated and just as effective.”
Despite the promising results, additional research is needed to determine whether Lipfendra can also reduce the risk of heart attacks, strokes, and cardiovascular deaths. Merck has indicated that results from a large clinical trial are expected to be available in 2029.
Dr. Siegel added, “Steve Nissen, longtime head of preventive cardiology at Cleveland Clinic, tells me that the lower the better when it comes to LDL cholesterol, especially in those at risk for heart disease.”
With the approval of Lipfendra, patients now have a new and effective option for managing high cholesterol, potentially transforming the landscape of cholesterol treatment.
According to Fox News, this development marks a significant advancement in the fight against high cholesterol and its associated health risks.