Reuters —
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 potential 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.
