Lexicon Reports the US FDA’s Acceptance of NDA for Sotagliflozin to Treat Heart Failure
Shots:
- The NDA was based on the P-III (SOLOIST-WHF) study in 1222 patients with T2D who had recently been hospitalized for worsening HF & P-III (SCORED) study in 10,584 patients with T2D, CKD & risks for CV disease evaluating the CV efficacy of sotagliflozin (SGLT1 & 2 inhibitors) vs PBO when added to SoC. The US FDA has assigned a PDUFA date for the NDA filing in May 2023
- Sotagliflozin has the potential to reduce the risk of CV death, hospitalization for HF & urgent HF visit for HF along with nonfatal myocardial infarction & stroke for T2DM, CKD & other CV risk factors
- In (SOLOIST-WHF) & (SCORED) study, the no. of 1EPs events per 100 patient yrs. (51.0 & 5.6 vs 76.3 & 7.5). The overall tolerability profile of sotagliflozin was similar to PBO
Ref: GlobalNewswire | Image: Lexicon
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