The Taiwan Food and Drug Administration has granted accelerated approval designation (AAD), and South Korea’s Ministry of Food and Drug Safety Orphan Drug Designation (ODD) for Nefecon to treat primary IgA nephropathy
Chinese biopharmaceutical company Everest Medicines said that regulatory authorities in Taiwan and South Korea have granted fast-tracked approval process for Nefecon.
Nefecon is a patented oral, delayed release formulation of budesonide, a corticosteroid that shows strong glucocorticoid activity and weak mineralocorticoid activity.
It is designed as an enteric coated capsule, to ensure that it stays intact until it reaches the Peyer’s patch region of the lower small intestine.
The Taiwan Food and Drug Administration has granted Accelerated Approval Designation (AAD) to Nefecon, to treat primary immunoglobulin A (IgA) nephropathy.
The AAD enables NDA submission and priority review of Nefecon based on results from Part A of Phase 3 NefIgArd clinical trial, announced in April this year.
South Korea’s Ministry of Food and Drug Safety granted Orphan Drug Designation (ODD) for Nefecon, which enables NDA filing and approval with priority review designation.
Nefecon is the lead product in its renal disease portfolio, and is the first treatment for primary IgA nephropathy, said the company.
Everest Medicines chief executive officer Rogers Yongqing Luo said: “We are very pleased to receive accelerated review and approval process for Nefecon in Taiwan and South Korea, which will help bring this therapeutic option to patients in Asia faster.
“While primary IgAN has much higher prevalence in Asia than elsewhere in the world, there are no established treatments for patients living with the chronic condition, underscoring the significant and urgent unmet need for this innovative medicine.”
In June 2019, Everest Medicines has entered an exclusive, royalty-bearing license agreement with Calliditas, a Sweden-based biopharmaceutical company.
Under the license agreement, Everest Medicines has obtained exclusive rights to develop and commercialise Nefecon in Mainland China, Hong Kong, Macau, Taiwan, and Singapore.
The agreement was extended in March 2022 to include South Korea.
Earlier this month, the China National Medical Products Administration (NMPA) accepted Everest Medicines’ NDA for Nefecon in mainland China,
In December 2020, the NMPA recommended Breakthrough Therapy Designation (BTD) for Nefecon for the treatment of IgAN.
Nefecon is already approved in the US and the EU, and is marketed under the brand names TARPEYO and Kinpeygo respectively.