Shots:
- China’s NMPA has granted full approval to sNDA of Nefecon to reduce kidney function loss in adults with primary IgAN at risk of disease progression, regardless of their proteinuria levels
- Approval was based on global P-III (NefIgArd) trial assessing Nefecon (16mg, QD, PO) vs PBO in above pts on RASi therapy over 2yrs. (9mos. therapy + 15mos. follow-up), which showed eGFR benefit & reduced UPCR as well as microhematuria in pts; In Chinese cohort, it reduced kidney function loss by 66% & delayed dialysis or transplant by 12.8yrs.
- Nefecon is now available in mainland China, Hong Kong, Macau, & Singapore, with launches expected in Taiwan (China) & South Korea by late 2025
Ref: PRNewswire | Image: Everest Medicines
Related News:- China’s NMPA Approves Akeso’s Ebdarokimab (IL-12/IL-23 Dual-Targeted mAb) for Moderate to Severe Plaque Psoriasis
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