FDA Approves Merck’s New Cholesterol Pill Lipfendra

Merck has announced that the Food and Drug Administration (FDA) has approved its new cholesterol-reducing pill, Lipfendra. This is the first approval of a pill of its kind, stepping away from conventional treatments like statins. Lipfendra is a PCSK9 inhibitor that blocks the protein PCSK9, which is important for controlling cholesterol levels.

Merck is broadening its focus with this new drug, as its cancer treatment, Keytruda, faces patent expiration in 2028. This expiration could introduce competition from more affordable biosimilar drugs. Lipfendra, also known as enlicitide, targets patients suffering from hypercholesterolemia, a condition marked by high levels of LDL cholesterol in the blood. LDL, often termed “bad” cholesterol, can cause artery plaque buildup.

With the FDA’s nod, Lipfendra stands as the first oral PCSK9 inhibitor on the market, offering an alternative to injectable cholesterol-lowering drugs. The pill is priced at $10.50 per day for a 30-day supply, as shared by the company. Following this announcement, Merck’s shares increased by 1.1% in premarket trading.

Approximately 25% of U.S. adults deal with high LDL cholesterol, according to the American Heart Association. Lipfendra was approved based on findings from two late-stage clinical trials. These trials demonstrated that the daily pill effectively reduced LDL cholesterol in many patients, including those with familial hypercholesterolemia and those already using statins.

The current market for cholesterol-lowering medications is largely held by injectable PCSK9 inhibitors, such as Amgen’s Repatha and Regeneron and Sanofi’s Praluent. Ahead of Lipfendra’s approval, Scotiabank analyst Louise Chen estimated that the drug could reach peak sales in tens of billions of dollars.

Notably, Lipfendra received expedited review under the FDA commissioner’s National Priority Voucher program. This program aims to speed up the evaluation of drugs that are crucial for public health or national security.