(Updates shares, adds analyst comments in paragraphs 9 and 10, and details from statement in paragraph 7) By Khushi Mandowara, May 26 (Reuters) – The U.S. Food and Drug Administration (FDA) has approved Lexicon Pharmaceuticals Inc’s drug for broad-spectrum treatment. Heart failure, including adult patients with type 2 diabetes, the company said on Friday. Shares of the company rose 13 percent in extended trading. The company’s first oral drug, sotagliflozin, was approved by the U.S. Food and Drug Administration and is sold under the brand name Inpefa. Previously, insulin therapy for type 1 diabetes failed to gain additional US approval. Sotagliflozin is a class of medication that helps control blood glucose levels and reduce weight gain by inhibiting SGLT1 and SGLT2 proteins. Jardiance, a member of the same class of drugs made by Eli Lilly and Boehringer Ingelheim, has been approved by the US regulator for the same indication. Lexicon, which plans to launch the drug by the end of June, expects the wholesale price of the drug to be on par with existing brand name heart failure drugs. The drug’s main competitor, Lilly Jardines, has a current list price of $570.48 for a one-month supply. Sotagliflozin offers a unique proposition in heart failure, especially given the drug’s unique benefits for hospitalized patients compared to current treatments, Pepper Sandler analyst Yasmin Rahimi said before the approval. Rahimi in 2010 Sales of $112 million in 2025 and $576 million in 2028. Lexicon is reportedly partnering with French drugmaker Sanofi SA to produce the drug. However, Sanofi parted ways with Lexicon after paying a $260 million termination fee. The FDA’s approval of the drug was based on a late-stage study that, compared with a placebo, reduced the risk of cardiovascular death and hospitalization for heart failure in adults with type 2 diabetes or certain other medical conditions. (Reporting by Khushi Mandowara and Maryam Sunny in Bengaluru; Editing by Shailesh Kuber and Anil D’Silva)
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