India, July 16 -- Merck (MRK) announced that the U.S. FDA has approved LIPFENDRA (enlicitide) tablets, the first and only once-daily oral PCSK9 inhibitor for adults with hypercholesterolemia, including heterozygous familial hypercholesterolemia (HeFH).
The approval marks a major milestone in cholesterol management, offering patients a convenient pill option alongside diet and exercise.
LIPFENDRA is a novel macrocyclic peptide designed to block PCSK9, a protein that interferes with LDL receptor function. By inhibiting PCSK9, the drug helps lower low-density lipoprotein cholesterol (LDL-C), commonly known as "bad cholesterol."
The approval was supported by results from two Phase 3 trials in the CORALreef program. In CORALreef Lipids, LIPFE...