← All storiesHealthDeveloping story Merckâs cholesterol pill gets US FDA approval | CNN
Merck said on Thursday the U.S. FDA has approved its cholesterol pill, the first of its kind to receive the health regulatorâs ânod, bolstering the drugmakerâs efforts to diversify beyond its blockbuster âcancer 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 âa drug intended to treat patients with hypercholesterolemia, which can âbe identified by elevated levels of LDL, the so-called âbadâ cholesterol â in the blood, often leading to plaque buildup in the arteries. With the âU.S. Food and Drug Administrationâs approval, Lipfendra, also called enlicitide, would become âthe 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 âplays a vital role in regulating cholesterol levels, while oral statins, an âolder type of cholesterol medicine, block an enzyme the liver uses to make cholesterol. About âone â in four adults in the U.S. have high LDL cholesterol, according to the Ameri

Jul 16, 2026
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