FDA rejects Sanofi, Lexicon's Zynquista for type 1 diabetes

Sanofi and Lexicon Pharmaceuticals announced Friday that the FDA issued a complete response letter to their filing seeking approval of the dual SGLT1 and SGLT2 inhibitor Zynquista (sotagliflozin) for the treatment of adults with type 1 diabetes in combination with insulin. The companies indicated that they intend to work with the FDA while determining their next steps. Shares in Lexicon were down as much as 29 percent on the news. 

In January, an FDA advisory panel was split regarding whether to back approval of Zynquista, while agency staff had expressed concern about the higher, and potentially unpredictable, risk of diabetic ketoacidosis among patients treated with the drug.

Data unveiled in 2017 from the Phase III inTandem3 study of patients with type 1 diabetes on continuous subcutaneous insulin infusion or multiple daily injection therapy showed that Zynquista was linked to a higher proportion of patients with glycosylated A1C levels less than 7 percent, as well as no episodes of severe hypoglycaemia or diabetic ketoacidosis. Zynquista also met the primary endpoints of the Phase III inTandem1 and inTandem2 trials.

Wedbush analyst Liana Moussatos had previously predicted US sales of more than $450 million for Zynquista by 2024 in the treatment of type 1 diabetes. Meanwhile, a number of SGLT2 inhibitors, including AstraZeneca and Bristol-Myers Squibb's Farxiga (dapagliflozin), Johnson & Johnson's Invokana (canagliflozin) and Eli Lilly and Boehringer Ingelheim's Jardiance (empagliflozin), have been authorised by the FDA for use in patients with type 2 diabetes. 

Sanofi gained rights to Zynquista under a 2015 deal with Lexicon potentially worth $1.7 billion. Meanwhile, the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion backing approval of the drug earlier this month for adults with type 1 diabetes. 

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