FDA Approves Merck’s Oral Cholesterol Pill Lipfendra

Merck has announced the approval of its cholesterol-lowering pill, Lipfendra, by the Food and Drug Administration (FDA). This marks the first oral PCSK9 inhibitor to receive approval, offering a new option for patients with hypercholesterolemia.

Lipfendra, also known as enlicitide, is designed to treat elevated LDL cholesterol levels. It achieves this by blocking the PCSK9 protein, which is crucial for cholesterol regulation. This mechanism differs from that of traditional statins, which inhibit a liver enzyme responsible for cholesterol production.

The approval is a strategic move for Merck as it diversifies its portfolio beyond its successful cancer treatment, Keytruda, which faces patent expirations starting in 2028. The introduction of Lipfendra is expected to provide robust competition against existing PCSK9 inhibitor injectables such as Amgen’s Repatha and Regeneron and Sanofi’s Praluent.

Merck has set Lipfendra’s list price at $10.50 per day for a 30-day supply. Following this announcement, the company’s shares saw a 1.1% increase in premarket trading.

The FDA based its approval on two late-stage trials. These trials revealed that Lipfendra significantly reduced LDL cholesterol levels in a wide patient demographic, including individuals with familial hypercholesterolemia or those already on statins.

Currently, one in four adults in the U.S. has high LDL cholesterol, highlighting the demand for effective treatments. Analyst Louise Chen from Scotiabank has projected that Lipfendra might achieve peak sales in the tens of billions of dollars.

Lipfendra also benefits from the FDA commissioner’s National Priority Voucher program, aimed at accelerating the review process for drugs critical to public health or national security.