May 26 (Reuters) – The U.S. Food and Drug Administration (FDA) said on Friday it had approved a drug from Lexicon Pharmaceuticals Inc (LXRX.O) for the broad treatment of heart failure, including in adults with type 2 diabetes. bottom.
The company’s shares rose 13% in extended trading.
Sotagliflozin, an oral drug, is the company’s first to be approved by the US Health Agency and will be marketed under the brand name Inpefa. Until now, it has not been approved in the United States as an add-on to insulin therapy for type 1 diabetes.
Sotagliflozin belongs to a class of drugs that regulate blood sugar levels and reduce the risk of weight gain by inhibiting the SGLT1 and SGLT2 proteins.
Jardiance, a drug in the same class developed by Eli Lilly (LLY.N) and Boehringer Ingelheim, has already been approved by US regulators for the same indication.
Lexicon, which plans to launch the drug by the end of June, said wholesale prices for the drug are expected to be similar to existing brands of heart failure drugs.
The current list price for the drug’s main competitor, Lily’s Jardiance, is $570.48 for a month’s supply.
Piper Sandler analyst Yasmeen Rahimi said that prior to approval, sotagliflozin was a unique proposition in heart failure, especially given the drug’s differentiated benefits in hospitalized patients compared to existing therapies. said it is offering
Rahimi estimates that sales of the drug will reach $112 million by 2025 and about $576 million by 2028.
Lexicon partnered with French pharmaceutical company Sanofi SA (SASY.PA) to develop the drug. However, Sanofi later parted ways with Lexicon after paying a $260 million release fee.
FDA approval is based on late-stage studies showing that the drug reduces the risk of cardiovascular death and hospitalization for heart failure in adults with type 2 diabetes and certain other health conditions when compared to placebo. .
Reported by Khushi Mandwara and Mariam Sunny of Bangalore. Edited by Shailesh Kuber and Anil D’Silva
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