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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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.
