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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