Sanofi (Euronext:SAN; NYSE:SNY) and partner Lexicon Pharmaceuticals Inc. (NASDAQ:LXRX) said FDA accepted an NDA for Zynquista sotagliflozin as an add-on to insulin therapy to improve glycemic control in adults with Type I diabetes. The PDUFA date is March 22.
The companies said the dual sodium-glucose cotransporter 1 (SGLT1) and SGLT2 inhibitor could be the first oral Type I diabetes therapy to be approved for adults in combination with insulin. The candidate is also under review in Europe to treat Type I diabetes in adults.
Lexicon said last year that the product increased the risk of diabetic ketoacidosis in the Phase III inTandem3 trial to treat Type I diabetes. Since 2015, FDA has required SGLT2 inhibitor labels to carry warnings about the risks of ketoacidosis and serious urinary tract infections (see BioCentury Extra, Sept. 13, 2017).
Lexicon was unchanged at $9.85 in afternoon trading on Tuesday.