FDA issues complete response letter for sotagliflozin
The FDA on Friday issued a complete response letter regarding a new drug application for oral sotagliflozin, a first-in-class dual SGLT1 and SGLT2 inhibitor for adult with type 1 diabetes, according a press release from Sanofi and Lexicon.
The FDA issues a complete response letter to an applicant if the agency determines that it will not approve the application or abbreviated application in its present form for one or more reasons.
In January, the Endocrinologic and Metabolic Drugs Advisory Committee voted 8-8 in a decision on whether to recommend approval of sotagliflozin (Zynquista), with several members expressing concerns about an observed risk in diabetic ketoacidosis and calling for a risk evaluation and mitigation strategy if the therapy is approved.
In discussion following the split decision, committee members who voted both in favor of and against approving the drug cited similar concerns about incidence of diabetic ketoacidosis (DKA) observed across three phase 3 trials, which the FDA noted was the most notable and concerning adverse reaction associated with sotagliflozin. In agency analyses, sotagliflozin was associated with an approximately eightfold increase in DKA risk vs. placebo (95% CI, 3.1-19.9). The estimated number needed to harm was approximately 26 patient-years of exposure to sotagliflozin to observe 1 additional DKA event, according to the FDA (95% CI, 20.1-38.5)
In the release, Sanofi and Lexicon stated they will work closely with the FDA to determine the appropriate next steps. – by Regina Schaffer