China-based Everest Medicines (HKG: 1952) has announced receiving Accelerated Approval Designation (AAD) from the Taiwan Food and Drug Administration and Orphan Drug Designation (ODD) from the Ministry of Food and Drug Safety in South Korea for its lead product Nefecon (targeted-release budesonide). These designations are for the treatment of primary immunoglobulin A nephropathy (IgAN) and are expected to significantly accelerate the New Drug Application (NDA) filing and approval process, increasing the likelihood of priority review designation.
Product Profile and Development
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. 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 also received Orphan Drug Designation in the US and European Union (EU) and Breakthrough Therapy Designation (BTD) in China in December 2020. It obtained marketing approvals in the US in December 2021 and in the EU in July 2022.
Clinical and Market Progress
IgAN affects approximately five million people in China, where there is currently no targeted therapy. In April 2022, Everest Medicines announced that reduction in proteinuria and stabilization of eGFR in a Chinese subpopulation after nine months of treatment with Nefecon were consistent with topline results from Part A of the pivotal global Phase 3 clinical trial NefIgArd. These results were reported by Calliditas Therapeutics AB in November 2020. Results from Part A of the NeflgArd study, published in Kidney International in October 2022, showed that the urine protein-to-creatinine ratio (UPCR) was 27% lower in the Nefecon group at nine months of treatment compared with the placebo, along with a benefit in eGFR preservation corresponding to a 3.87 ml/min/1.73 m2 difference versus placebo. Nefecon was also well-tolerated. This month, Everest made a market filing for the drug in China for IgAN treatment.-Fineline Info & Tech
