Singapore HSA Accepts NDA of Everest Medicines’ Nefecon for the Treatment of Primary IgA Nephropathy
- 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: PR Newswire | Image: Everest Medicines
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