Lexicon Reports Submission of NDA to the US FDA for Sotagliflozin to Treat Heart Failure in Adults with Type 2 Diabetes
Shots:
- The company has submitted an NDA to the US FDA for the approval of sotagliflozin to reduce the risk of cardiovascular death, hospitalization & urgent visits for HF in adult patients with T2D with either worsening HF or additional risk factors irrespective of LVEF
- The submission is based on the P-III (SOLOIST) & (SCORED) clinical study to evaluate the cardiovascular efficacy of sotagliflozin vs PBO when added to SoC in 1,222 & 10,584 patients with T2D. Additionally, both trials meet their 1EPs with overall tolerability similar to PBO
- Sotagliflozin is an oral dual inhibitor of two proteins that were responsible for glucose regulation i.e., SGLT1 and SGLT2
Ref: Globe Newswire | Image: Lexicon
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