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.
But their pitch was ultimately snubbed, for reasons they never really divulged. Sanofi extricated itself from the alliance before the FDA declined Lexicon’s appeal to the complete response letter, and rival SGLT2 inhibitors such as Eli Lilly and Boehringer Ingelheim’s Jardiance, as well as AstraZeneca’s Farxiga, got far ahead.
One issue that did surface, during an adcomm that voted 8-8 ahead of the initial rejection, was the high risk of diabetic ketoacidosis. It’s a condition that can be hard to spot, raising the chances of hospitalization for patients who are unaware that they urgently need to take insulin.
The biotech eventually switched tack, testing sotagliflozin for its potential to reduce the risk of cardiovascular death, hospitalization and urgent visits for heart failure in high-risk adults with type 2 diabetes.
Across two Phase III trials, sotagliflozin reduced the total number of those cardiovascular events among both patients with type 2 diabetes who had recently been hospitalized for worsening heart failure, and those with type 2 diabetes, chronic kidney disease and risks for cardiovascular disease.
It started a resubmission last December, then pulled it again in March “to correct a technical issue with the submission recently identified by the company.”
Following a rollercoaster ride, Lexicon shares $LXRX are now hovering around $1.80.