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Lexicon Reports the US FDA’s Acceptance of NDA for Sotagliflozin to Treat Heart Failure

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Lexicon Reports the US FDA’s Acceptance of NDA for Sotagliflozin to Treat Heart Failure

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  • 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

Click here to­ read the full press release 

Senior Editor

Neha is a Senior Editor at PharmaShots. She is passionate and very enthusiastic about recent updates and developments in the life sciences and pharma industry. She covers Biopharma, MedTech, and Digital health segments along with different reports at PharmaShots. She can be contacted at connect@pharmashots.com.

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