PARIS (dpa-AFX) - Lexicon Pharmaceuticals, Inc. (LXRX) said that the Endocrinologic and Metabolic Drugs Advisory Committee of the U.S. Food and Drug Administration voted eight to eight on the question of whether the overall benefits of Zynquista or sotagliflozin outweighed the risks to support approval.
Sotagliflozin is an investigational oral dual SGLT1 and SGLT2 inhibitor under regulatory review as an adjunct to insulin for the treatment of adults with type 1 diabetes (T1D). While the FDA is not required to follow the committee's vote, the agency considers the committee's recommendations when making its decision, which is anticipated by March 22, 2019.
Sotagliflozin, developed by Sanofi and Lexicon, has the potential to be the first oral antidiabetic drug approved in the United States together with insulin therapy to improve glycemic (blood sugar) control in adults with T1D.
Sanofi also submitted a regulatory application to the European Medicines Agency (EMA) in 2018. An EMA approval decision is expected in the first half of 2019.
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