FDA Approves Merck’s Cholesterol-Lowering Pill Lipfendra

The Food and Drug Administration has granted approval to Merck’s new cholesterol pill, Lipfendra. This marks the first pill of its kind to receive approval, aiming to strengthen Merck’s product range beyond its cancer treatment, Keytruda.

Keytruda, Merck’s blockbuster cancer drug, is facing the expiration of key patents starting in 2028, which could lead to competition from cheaper biosimilars. Lipfendra, scientifically known as enlicitide, is designed to treat patients with hypercholesterolemia. This condition is identified by high levels of LDL, commonly referred to as ‘bad’ cholesterol, which can cause plaque buildup in arteries.

With FDA approval, Lipfendra becomes the first oral PCSK9 inhibitor available on the market. This provides an alternative to existing injectable cholesterol-lowering medications. The approved list price for Lipfendra is $10.50 per day for a 30-day supply. Following the announcement, Merck’s shares increased by 1.1% in premarket trading.

Unlike statins, which block a liver enzyme responsible for cholesterol production, Lipfendra works by inhibiting the PCSK9 protein. This protein is integral to cholesterol regulation in the body. According to the American Heart Association, approximately one in four adults in the U.S. experience high LDL cholesterol.

The FDA based its approval on two late-stage clinical trials. These studies demonstrated that the once-daily pill significantly reduced LDL cholesterol across diverse patient groups, including those with familial hypercholesterolemia and those already on statins.

The current market for cholesterol-lowering drugs has been dominated by PCSK9-inhibitor injectables such as Amgen’s Repatha and the Praluent from Regeneron and Sanofi. Analyst Louise Chen from Scotiabank suggested that Lipfendra could reach peak sales in the tens of billions of dollars.

Merck’s Lipfendra also benefits from the FDA commissioner’s National Priority Voucher program. This initiative accelerates the review period for drugs that are deemed critical to public health or national security.