Merck has announced the FDA’s approval of its cholesterol-lowering pill Lipfendra. Notably, Lipfendra is the first oral PCSK9 inhibitor, offering a new option for patients with hypercholesterolemia. This approval marks a significant advancement for Merck as it seeks to diversify beyond its cancer treatment, Keytruda.
The approval of Lipfendra comes at a crucial time for Merck. Keytruda’s patent protections will begin to expire in 2028, potentially increasing competition from cheaper biosimilar drugs. With Lipfendra, Merck establishes itself in a different market segment.
Lipfendra functions by inhibiting the PCSK9 protein. This protein is essential in controlling cholesterol levels. In comparison, older oral statins block an enzyme responsible for cholesterol production in the liver.
The pill aims to help individuals with high levels of LDL cholesterol, known as the ‘bad’ cholesterol. Elevated LDL cholesterol can lead to plaque buildup in arteries, posing significant health risks. The American Heart Association reports that one in four American adults have high LDL cholesterol.
“Its list price will be $10.50 per day based on a 30-day supply,” Merck disclosed. This announcement influenced a notable 1.1% rise in Merck’s shares during premarket trading.
FDA approval followed two late-stage trials. These trials indicated that Lipfendra effectively lowered LDL cholesterol in varied patient groups, including those with familial hypercholesterolemia and those already using statins.
Currently, the market for cholesterol-lowering drugs is largely dominated by injectable PCSK9 inhibitors like Amgen’s Repatha and Praluent by Regeneron and Sanofi. Lipfendra presents a much-needed oral alternative.
Analyst Louise Chen from Scotiabank projected Lipfendra’s peak sales might reach tens of billions of dollars.
Merck benefitted from the FDA commissioner’s National Priority Voucher program. This initiative seeks to expedite the review of drugs vital to public health or national security.