Merck said on Thursday the U.S. FDA has approved its cholesterol pill, the first of its kind to receive the health regulator’s nod, bolstering the drugmaker’s efforts to diversify beyond its blockbuster cancer treatment Keytruda.
Keytruda is set to lose key patent protections starting in 2028, exposing the company to competition from potentially less expensive biosimilar versions of the drug.
Lipfendra is a drug intended to treat patients with hypercholesterolemia, which can be identified by elevated levels of LDL, the so-called “bad” cholesterol in the blood, often leading to plaque buildup in the arteries.
With the U.S. Food and Drug Administration’s approval, Lipfendra, also called enlicitide, would become the first oral PCSK9 inhibitor to enter the market, offering an alternative to a class of cholesterol-lowering drugs long dominated by injectables.
It works by blocking PCSK9 protein, which plays a vital role in regulating cholesterol levels, while oral statins, an older type of cholesterol medicine, block an enzyme the liver uses to make cholesterol.
About one in four adults in the U.S. have high LDL cholesterol, according to the American Heart Association.
The FDA’s decision was based on two late-stage trials, which showed the once-daily pill significantly lowered LDL cholesterol in a broad range of patients, including those with familial hypercholesterolemia and those already taking statins.
The landscape for cholesterol-lowering drugs is currently dominated by PCSK9-inhibitor injectables such as Amgen’s Repatha, and Regeneron and Sanofi’s Praluent.
Lipfendra could have “peak sales potential of tens of billions of dollars,” Scotiabank analyst Louise Chen had said ahead of the approval.
Merck’s drug is a recipient of the FDA commissioner’s National Priority Voucher program, which is intended to slash review periods of drugs that are critical to public health or national security.
