FDA snubs Sanofi, Lexicon on their pitch for SGLT1/2 diabetes drug sotagliflozin, companies mum on what went wrong
Sanofi’s shot at a last-place showing for its SGLT1/SGLT2 diabetes drug has ended in a painful pratfall ahead of the finish line. The pharma giant and their partners at Lexicon $LXRX say that sotagliflozin, a major player for their diabetes portfolio, has been rejected by the FDA.
Their terse release gave no explanation for what went wrong, but an expert panel provided a split vote on the money question regarding safety and efficacy, with insiders at the agency fielding big concerns about evidence of diabetic ketoacidosis.
Unlock this article instantly by becoming a free subscriber.
You’ll get access to free articles each month, plus you can customize what newsletters get delivered to your inbox each week, including breaking news.