Calliditas: China CDE/NMPA Recommends Priority Review for IgA Nephropathy Treatment

  Calliditas Therapeutics AB (publ) ("Calliditas") partner Everest Medicines (HKEX 1952.HK) today announced that the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) has recommended Priority Review for the New Drug Application (NDA) of Nefecon for the treatment of primary immunoglobulin A nephropathy (IgAN) in adults at risk of rapid disease progression.

In November 2022 the NMPA accepted Everest's NDA for Nefecon, leading to an expected regulatory decision in 2H 2023. Priority review has the potential to accelerate the regulatory review.

https://www.biospace.com/article/releases/china-cde-nmpa-recommends-priority-review-for-nefecon-for-the-treatment-of-primary-iga-nephropathy/