Lexicon’s Inpefa (sotagliflozin) Receives the US FDA’s Approval for the Treatment of Heart Failure
Shots:
- The US FDA has approved Inpefa to reduce the risk of cardiovascular death, hospitalization for HF, and urgent heart failure visits in adults with HF or type 2 diabetes mellitus, CKD, and other cardiovascular risk factors
- The approval was based on the 2 P-III studies (SOLOIST-WHF) & (SCORED) in ~12000 patients. The (SOLOIST-WHF) trial results showed a reduction in risk of the composite of hospitalizations for HF, urgent visits for HF & cardiovascular death by 33% over PBO who had been recently hospitalized for worsening HF
- No. of 1EPs events per 100 patient-years was 51.3 vs 76.4 in (SOLOIST-WHF) trial; 5.6 vs 7.5 in (SCORED). The therapy is expected to be commercially available in the US at the end of June 2023
Ref: Lexicon | Image: Lexicon
Related News:- Lexicon Reports the US FDA’s Acceptance of NDA for Sotagliflozin to Treat Heart Failure
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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.
