Calliditas Therapeutics Reports the US Regulatory Update on Nefecon for the Treatment of IgA Nephropathy
Shots:
- The US FDA has accepted the sNDA & granted priority review of Nefecon with an expected decision on Dec 2023. The sNDA was based on the P-III study (NefIgArd) evaluating Nefecon (16mg, qd) vs PBO in adult patients with primary IgAN on optimized RASi therapy
- The results showed a significant benefit of Nefecon in eGFR over 2yr. study period consisted of 9mos. of treatment with Nefecon, followed by a 15mos. follow-up period of the study, treatment benefits across the entire study population regardless of UPCR baseline, and difference b/w Tarpeyo & PBO in 2yr. eGFR total slope of ~3mL/min per year. The results were published in The Lancet
- Nefecon received BTD from the NMPA & was also approved in the US under accelerated approval based on a reduction in proteinuria
Ref: PRNewswire | Image: Everest medicines
Related News:- Everest Medicines Partner Calliditas Publish P-III (NeflgArd) Trial Results of Nefecon for Primary IgA Nephropathy in The Lancet
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