Split FDA advisory panel vote on type 1 diabetes drug Zynquista

In an indecisive vote, The US Food and Drug Administration’s Endocrinologic and Metabolic Drugs Advisory Committee yesterday 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 French pharma major Sanofi Euronext: SAN)and Lexicon Pharmaceuticals (Nasdaq: LXRX), has the potential to be the first oral antidiabetic drug approved in the USA together with insulin therapy to improve glycemic (blood sugar) control in adults with T1D.