FDA advisory panel votes on Zynquista as treatments for adults with diabetes

FDA advisory committee votes on Zynquista as treatments for adults with diabetes  The 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 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. 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 (SNY) and Lexicon (LXRX), has the potential to be the first oral antidiabetic drug approved in the United States together with insulin therapy to improve glycemic control in adults with T1D.

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