Merck has secured FDA approval for Lipfendra, its internally developed cholesterol-lowering drug, marking a significant milestone in cardiovascular medicine.
Lipfendra, known scientifically as enlicitide, is a macrocyclic peptide that becomes the first oral PCSK9 inhibitor to reach the commercial market anywhere in the world.
The FDA has endorsed a 20-mg daily dose of Lipfendra to reduce low-density lipoprotein cholesterol, commonly referred to as LDL-C, in adults with hypercholesterolemia.
The approval also covers patients with heterozygous familial hypercholesterolemia, a hereditary condition that can dramatically elevate the risk of heart attack or stroke.
Until now, all approved PCSK9 treatments have required injection, making Lipfendra’s oral format a potentially transformative shift in how high cholesterol is managed.
Lipfendra carries a list price of $315 per month before discounts, roughly half the cost of rival PCSK9 products currently available, including Novartis’ blockbuster Leqvio, which uses siRNA technology.
Merck confirmed the drug will be made available through the direct-to-patient TrumpRx programme, and the pills can be stored at room temperature, adding to their convenience.
However, Lipfendra comes with a notable drawback, requiring patients to fast for eight hours before taking the drug and to wait 30 minutes afterward before eating, raising questions about long-term patient compliance.
Analyst consensus places Lipfendra’s annual peak sales at $5 billion, a figure Merck will be counting on as it braces for the looming patent cliff facing its cancer blockbuster Keytruda.
Keytruda generated $31.7 billion last year, accounting for 55% of Merck’s total revenue, making the search for compensating products a strategic priority for the company.
Investors responded positively to the approval news, pushing Merck’s share price up by 3% following the announcement.
With a competitive price point, oral convenience, and a clear commercial pathway, Lipfendra is positioned to become one of the more closely watched drug launches in the cardiovascular space this year.