FDA Approves Merck’s New Oral Cholesterol Drug Lipfendra

Merck’s new cholesterol-lowering pill, Lipfendra, has gained approval from the Food and Drug Administration (FDA). This pill is the first of its kind to receive approval, marking a significant step for Merck as it looks to expand beyond its current cancer treatment, Keytruda.

Keytruda faces upcoming patent expirations starting in 2028, increasing the potential for competition from less expensive biosimilars. The introduction of Lipfendra could diversify Merck’s product offerings significantly.

Lipfendra, also known as enlicitide, targets patients with hypercholesterolemia, characterized by high levels of LDL cholesterol. High LDL, often referred to as “bad” cholesterol, can result in plaque buildup within arteries.

With its FDA approval, Lipfendra becomes the first oral PCSK9 inhibitor available, providing an alternative to cholesterol-lowering injectables. PCSK9 inhibitors, such as those from Amgen and from Regeneron and Sanofi, have previously dominated this space.

The pill works by blocking the PCSK9 protein, crucial in cholesterol regulation. In contrast, oral statins, an older form of cholesterol medication, inhibit an enzyme used by the liver to produce cholesterol.

A 30-day supply of Lipfendra is priced at $10.50 per day, Merck reported. Following this announcement, Merck’s shares saw a 1.1% increase in premarket trading.

Data from the American Heart Association indicates that one in four adults in the U.S. have elevated LDL cholesterol levels.

The FDA approval follows two late-stage trials demonstrating that the once-daily Lipfendra pill significantly reduced LDL cholesterol levels. This reduction was noted in a broad spectrum of patients, including those with familial hypercholesterolemia and those already on statins.

Louise Chen, a Scotiabank analyst, projected that Lipfendra could achieve peak sales in the tens of billions of dollars. This forecast reflects the potential demand for an oral PCSK9 inhibitor.

As a part of the FDA commissioner’s National Priority Voucher program, Lipfendra’s review process was expedited. This program is designed to hasten the approval of drugs vital to public health or national security.