China-based Everest Medicines (HKG: 1952) has announced that South Korea’s Ministry of Food and Drug Safety (MFDS) has included the firm’s Nefecon (targeted-release formulation-budesonide) in the Global Innovative Fast Track (GIFT) program for the treatment of primary immunoglobulin A nephropathy (IgAN). This designation is a significant step in the development and potential approval of Nefecon in South Korea.
Previous Designations and Agreements
Nefecon was previously granted orphan drug designation (ODD) status by the MFDS. In June 2019, Everest Medicines entered into an exclusive, royalty-bearing license agreement with Calliditas, which gives 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 as part of Everest’s territories. The drug, with orphan drug designations (ODDs) in the US and EU, was approved for marketing in the EU in July of last year.
Clinical Data and Efficacy
Data published in April 2022 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 found to be effective and well tolerated. Based on these positive results, Everest Medicines filed Nefecon for approval to treat primary IgA nephropathy in China in November of the same year.-Fineline Info & Tech
