Lexicon’s type 1 diabetes drug is finally getting another shot at the FDA.
The biotech announced Friday morning that it had officially resubmitted a new drug application for sotagliflozin following a CRL five years ago. Regulators rejected the drug back in 2019 due to safety issues and previously denied multiple appeals to the ruling.
But in 2023, the path appeared easier once the FDA allowed discussions to go forward about a potential resubmission, Lexicon said at the time. The company and the agency ultimately agreed on the best way forward in March, involving a narrower indication as an adjunct to insulin in patients with type 1 diabetes and chronic kidney disease.
Sotagliflozin is an SGLT1/2 inhibitor and will face a six-month review period, Lexicon said. Lexicon previously partnered with Sanofi to develop the drug, but the French pharma company walked away after the 2019 rejection.