Lexicon pulls FDA submission for sotagliflozin to fix 'technical issue,' plans prompt refiling

Eli Lilly and Boehringer Ingelheim recently celebrated a heart failure FDA label expansion for their SGLT 2 drug, Jardiance, and now a potential rival from Lexicon Pharmaceuticals has suffered a regulatory setback.

On Monday, Lexicon reported that it had to pull its recent FDA filing for sotagliflozin to fix a "technical issue" it identified in the filing. 

The company submitted its sotagliflozin FDA application late last year to reduce severe cardiovascular risks in type 2 diabetes patients. At the time, the company noted that the agency had 60 days to review the paperwork and determine if the application was "complete and acceptable."

Instead, Lexicon's own team has discovered an issue with the filing, CEO Lonnel Coats said on a Monday conference call. The company now plans to fix and "promptly resubmit the NDA early in the second quarter," he added. If the drug is approved, that timeline would put a potential U.S. launch in the first half of 2023.

RELATED: ESC 2021: Lexicon aims to make its heart failure case with sotagliflozin, a dual SGLT1 and SGLT2 inhibitor

Lexicon's setback comes right after Eli Lilly and Boehringer Ingelheim's Jardiance's approval was expanded last week to reduce the risk of cardiovascular death and hospitalization in adults with heart failure. That approval built on a prior nod for Jardiance to reduce the risk of hospitalization and death in patients with heart failure and low ejection fraction. And the latest FDA clearance made Jardiance the only med cleared to improve outcomes in all heart failure patients, no matter their ejection fraction status.

For its part, Lexicon is seeking FDA approval for sotagliflozin, a dual SGLT1 and SGLT2 inhibitor, to reduce the risk of cardiovascular death, hospitalization for heart failure and urgent visits for heart failure in adults with type 2 diabetes and certain risk factors.

Despite the delay, Coats said the setback could represent an opportunity for Lexicon to "strengthen" its application and seek a priority review in certain high-risk patients.

RELATED: Eli Lilly, Boehringer Ingelheim's Jardiance clinches heart failure edge with FDA nod for wider label

In 2019, sotagliflozin scored approval in Europe to treat type 1 diabetes in adults. The med has never scored an FDA approval.

Lexicon was previously collaborating with Sanofi on the drug, but the partners parted ways. In a 2019 settlement, Sanofi paid Lexicon $260 million and returned full rights to the drug.