The regulatory authorities in Taiwan and South Korea have granted fast-tracked approval process for Everest Medicines’ Nefecon.
The patented oral, delayed release formulation of budesonide, Nefecon, has been 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.
It is said to be the company’s lead product in its disease portfolio and is developed as a first-in-disease treatment for primary immunoglobulin A nephropathy (IgAN).
Nefecon received Accelerated Approval Designation (AAD) from the Taiwan Food and Drug Administration that enables submission of NDA.
The AAD also enables the priority review of Nefecon based on the results obtained from Part A of the pivotal global Phase III NefIgArd clinical trial.
South Korea’s Ministry of Food and Drug Safety has granted Orphan Drug Designation (ODD) for Nefecon.
Everest Medicines stated that the ODD expedites the NDA filing as well as the approval of Nefecon with priority review designation.
Everest Medicines CEO 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.”
Earlier this month, the China National Medical Products Administration (NMPA) accepted the company’s NDA for Nefecon in mainland China.
In December 2020, the NMPA recommended Breakthrough Therapy Designation (BTD) for Nefecon to treat IgAN.
Nefecon is already approved and marketed in the US and the EU, under the brand names, TARPEYO and Kinpeygo, respectively.