The European Medicines Agency's (EMA) advisory group has voted in favor of approving two new cholesterol-lowering medicines developed by biopharmaceutical company Esperion Therepeutics (NASDAQ:ESPR). Following the positive opinion from the Committee for Medicinal Products for Human Use (CHMP), formal approval of bempedoic acid by the EMA is anticipated in April.
Bempedoic acid reduces the production of low-density lipoprotein cholesterol (LDL-C) in the body by targeting ATP citrate lyase (ACL), an enzyme that plays an important role in fatty acid biosynthesis.
Esperion Therapeutics is seeking approval of single tablet bempedoic acid and a combination pill comprising bempedoic acid and Zetia, a blockbuster medication that reduces absorption of cholesterol from the gastrointestinal tract. If approved, these drugs could be used alongside or as an alternative to statins, a commonly prescribed class of medications used to lower LDL-C.
CHMP's opinion on bempedoic acid was supported by positive clinical trial results. In phase 3 studies, bempedoic acid lowered LDL-C by up to 18% when used alongside statins and by up to 28% when used without statins. The bempedoic acid and Zetia combination pill lowered LDL-C by 38% compared to placebo.
These results also support the company's applications for approval of the treatments in the United States. Decisions from the Food and Drug Administration are expected for those drugs on Feb. 21 and Feb. 26, respectively.
If they are approved, Esperion's European commercialization partner, Daiichi Sankyo, will market the drugs in Europe. In the U.S., Esperion Therapeutics will commercialize the drugs itself.
In the U.S., 96 million people have elevated LDL-C, including 18 million people with atherosclerotic cardiovascular disease (ASCVD) who have elevated bad cholesterol levels, despite taking statins.