U.S. FDA approves Lexicon Pharma’s heart failure drug
2023.05.26 17:25
© Reuters. FILE PHOTO: Signage is seen outside of the Food and Drug Administration (FDA) headquarters in White Oak, Maryland, U.S., August 29, 2020. REUTERS/Andrew Kelly/File Photo
(Reuters) -The U.S. Food and Drug Administration (FDA) has approved Lexicon Pharmaceuticals (NASDAQ:) Inc’s drug as a broad treatment for heart failure patients, including those with type 2 diabetes, the company said on Friday.
Shares in the company rose 17% in volatile after market trading, before paring gains to trade up around 10%.
The drug, sotagliflozin, to be sold under the brand name Inpefa, is the first Lexicon treatment to be approved in the country. The drugmaker had failed to secure approval from the U.S. health agency for the drug that was an add-on to insulin therapy for type 1 diabetes in 2019.
In 2019, the FDA had declined to approve the drug citing the risk of diabetic ketoacidosis (DKA), a life-threatening condition in which acids called ketones build up when the body starts to use fat instead of glucose as a source of energy, in patients with type 1 diabetes.
