Everest Medicines’ Nefecon Receives Priority Review Recommendation from CDE

China-based Everest Medicines (HKG: 1952) has announced that the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) has recommended Priority Review status for the New Drug Application (NDA) of Nefecon (targeted-release formulation-budesonide) for the treatment of primary immunoglobulin A nephropathy (IgAN) in adults at risk of rapid disease progression. Nefecon was previously granted Breakthrough Therapy Designation status for IgAN.

About Nefecon and IgAN
Nefecon is a patented oral, delayed-release formulation of budesonide, a corticosteroid with potent glucocorticoid activity and weak mineralocorticoid activity, that undergoes substantial first-pass metabolism. Chronic kidney disease, including IgAN, is one of the diseases that seriously threatens public health in China, affecting 5 million people with no targeted treatment available. Nefecon represents the first drug in the past 50 years worldwide to treat IgAN.

Clinical Data and Market Filing
Data published in April of this year showed that, after nine months of Nefecon treatment, the results of decreased albuminuria and stable glomerular filtration rate (eGFR) in the Chinese population subgroup were consistent with the main results of NefIgArd A in the global Phase III clinical study. In the study, Nefecon was effective and well-tolerated. Everest Medicines made the market filing for Nefecon to treat primary IgAN in China in November.

Global Development and Regulatory Milestones
In June 2019, Everest Medicines entered into an exclusive, royalty-bearing license agreement with Calliditas, granting Everest Medicines exclusive rights to develop and commercialize Nefecon in mainland China, Hong Kong, Macau, Taiwan, and Singapore. The agreement was extended in March 2022 to include South Korea. Nefecon has received orphan drug designations (ODDs) in the US and European Union (EU) and was approved for marketing in the EU in July this year.-Fineline Info & Tech

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