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U.S. FDA approves Lexicon Pharma's drug for heart failure

FILE PHOTO: Signage is seen outside of FDA headquarters in White Oak, Maryland

By Khushi Mandowara

(Reuters) -The U.S. Food and Drug Administration (FDA) has approved Lexicon Pharmaceuticals Inc's drug for a broad treatment of heart failure, including in adult patients with type 2 diabetes, the company said on Friday.

Shares of the company rose 13% in extended trading.

The oral drug, sotagliflozin, is the company's first to be approved by the U.S. health agency and will be sold under the brand name Inpefa. It had previously failed to win U.S. approval as an add-on to insulin therapy for type 1 diabetes.

Sotagliflozin belongs to a class of medicine that helps regulate blood glucose levels and reduce the risk of weight gain by inhibiting SGLT1 and SGLT2 proteins.

Jardiance, a drug developed by Eli Lilly and Boehringer Ingelheim that belongs to the same class, has already been approved by the U.S. regulator for the same indication.

Lexicon, which plans to launch the drug by the end of June, said the medicine's wholesale price is expected to be on par with existing branded heart failure medications.

The current list price of Lilly's Jardiance, the drug's main competitor, is $570.48 for a month's supply.

Sotagliflozin presents a unique proposition in heart failure, especially considering the drug's differentiated benefit in hospitalized patients, compared with existing treatments, Piper Sandler analyst Yasmeen Rahimi said ahead of the approval.

Rahimi estimates the drug to rake in sales of $112 million by 2025 and about $576 million by 2028.

Lexicon partnered with French drugmaker Sanofi SA to develop the drug. However, Sanofi later parted ways with Lexicon after paying a $260 million termination fee.

The FDA approval was based on a late-stage study that showed the drug, when compared with a placebo, reduced the risk of cardiovascular death and hospitalization due to heart failure in adults with type 2 diabetes or certain other health conditions.

(Reporting by Khushi Mandowara and Mariam Sunny in Bengaluru; Editing by Shailesh Kuber and Anil D'Silva)