FDA unconvinced by Sanofi’s Zynquista in type 1 diabetes

Sanofi’s hopes of getting its dual SGLT inhibitor sotagliflozin approved alongside insulin for type 1 diabetes in the US have been dashed by the FDA. The US regulator has issued a complete response letter (CRL) for Lexicon Pharma-partnered sotagliflozin, a dual SGLT1 and SGLT2 inhibitor that has the proposed trade name of Zynquista, even though it has already been recommended for approval in Europe by the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP). Sanofi issued a terse statement in response to the FDA’s rejection of its application to use sotagliflozin in combination with insulin for the treatment of adults with type 1 diabetes, simply saying that it would “work closely with the FDA to determine the appropriate next steps.” So far, AstraZeneca’s Farxiga SGLT2 inhibitor (dapagliflozin) has also been recommended for approval as an oral add-on to insulin to improve blood sugar control in type 1 diabetes in the EU, getting a green light from the CHMP last month, and was also filed with the FDA for this indication last year.