FDA Approves New Cholesterol-Lowering Drug by Merck
On Thursday, the U.S. Food and Drug Administration (FDA) announced its approval of a new cholesterol-lowering medication from Merck & Co. This marks the first oral drug in a category typically filled with injectable options, potentially expanding treatment accessibility for those at risk for heart disease.
Branded Lipfendra, the tablet aims to help individuals with hypercholesterolemia, including those suffering from genetic conditions that lead to high levels of LDL cholesterol—often referred to as the “bad” cholesterol. High LDL can cause plaque to accumulate in arteries, raising the risk of cardiovascular issues. According to the American Heart Association, about 25% of adults in the U.S. struggle with elevated LDL cholesterol.
This new approval positions Lipfendra, known scientifically as enricitide, as the first oral option targeting PCSK9—a protein that plays a key role in baleful cholesterol levels and cardiovascular health.
In morning trading, Merck’s share price increased by 4% following the announcement.
The cost of Lipfendra will be around $10.50 per day, totaling approximately $315 monthly. Merck indicated that the drug would be available shortly.
Brian Ford, Merck’s executive vice president, noted that the medication is intended as a supplemental treatment for individuals already on existing cholesterol medications like statins. He pointed out that nearly 70% of patients undergoing such treatments are not achieving the recommended cholesterol levels, presenting a significant opportunity for Lipfendra.
Trung Huynh, an analyst at RBC Capital Markets, highlighted that this drug does not carry warnings about allergic reactions, unlike some of its injectable counterparts.
He elaborated that despite having injectable medications available for about a decade, around 70% of eligible patients with high-risk atherosclerotic cardiovascular disease remain under-treated, often due to factors like the discomfort of injections and challenges in obtaining prior authorizations.
Huynh predicts that Lipfendra could achieve peak sales of around $5 billion by 2034.
The FDA’s approval was grounded in two late-stage trials, which demonstrated that a daily pill could reduce LDL cholesterol levels by nearly 60% in those with hypercholesterolemia.
Merck is currently conducting further clinical trials to explore Lipfendra’s impact on cardiovascular health outcomes.
Other existing options for lowering cholesterol include injectable drugs like Amgen’s Repatha and Regeneron’s Praluent.
