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Calliditas Therapeutics Reports sNDA Submission to the US FDA for Tarpeyo to Treat Primary IgA Nephropathy

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Calliditas Therapeutics

Calliditas Therapeutics Reports sNDA Submission to the US FDA for Tarpeyo to Treat Primary IgA Nephropathy

Shots:

  • The company submits the sNDA to the US FDA seeking full approval of Tarpeyo for the treatment of adult patients with primary IgAN. The sNDA submission was based on the results from the P-III trial (NefIgArd) evaluating the efficacy & safety of Tarpeyo (16mg, qd) vs PBO on a background of optimized RASi therapy
  • The trial met its 1EPs & showed a significant benefit over PBO in eGFR over 2yr. period of 9mos. of treatment & 15mos. follow-up of the drug, reduction in UPCR was also durable with a 30.7% vs 1% reduction in UPCR after 15mos.
  • Calliditas collaborated with its EU commercial partner, STADA Arzneimettel AG to seek full approval of Nefecon in the EU across the full study population

Ref:  | Image: Calliditas

Related News:- Calliditas’s Tarpeyo (budesonide) Receives the US FDA’s Accelerated Approval for the Treatment of IgA Nephropathy

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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.

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