Will third time be the charm? Lexicon finally refiles SGLT2 drug for heart failure
Lexicon’s experimental treatment of heart failure is finally on its way to the FDA — again.
The Woodlands, TX-based biotech says it’s resubmitted an NDA to the FDA seeking to market sotagliflozin as a treatment for heart failure, kicking off the 60-day review period.
The resubmission comes almost exactly four years after US regulators first accepted sotagliflozin for review. Back in 2018, it was Lexicon’s then-partner, Sanofi, that did the filing. The companies had given the drug a brand name — Zynquista — and were touting how, if approved, it would be the first oral treatment option for adults with type 1 diabetes, in combination with insulin.
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