The NDA approval of Singapore HSA is expected in 2023. In Nov 2022, NDA was filed for Nefecon as a first-in-disease treatment therapy for IgAN patients in Mainland China and it is under priority review while approval is expected in H2’23
Earlier it received BTD from NMPA, GIFT designation from South Korea’s MFDS, and in Nov 2022, the Taiwan FDA granted AAD to Nefecon
Nefecon is an oral, enteric-coated delayed release capsule of budesonide with potent glucocorticoid activity and weak mineralocorticoid activity that undergoes first-pass metabolism. It is being developed and commercialized by Everest Medicines under a 2019 licensing agreement with Calliditas
Ref: Prnewswire | Image: Everest Medicines
Related News:- Calliditas’ Nefecon Meets its Primary Endpoint in P-III Trial (NefIgArd) for the Treatment of IgA Nephropathy
