-=Lexicon Pharma (LXRX) : FDA votes on type 1 diabetes mellitus treatment

• FDA AdCom votes 8-8 over whether to support sotagliflozin as an adjunct to insulin to improve glycemic control in adults with type 1 diabetes mellitus

Lexicon Pharma (LXRX) and Sanofi (SNY) confirm FDA Advisory Committee vote on Zynquista as treatment for adults with type 1 diabetes

• The Endocrinologic and Metabolic Drugs Advisory Committee of the FDA voted eight to eight on the question of whether the overall benefits of Zynquista (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 in 2018. An EMA approval decision is expected in the first half of 2019.