Earlier Reported, Everest Medicines' Partner Calliditas Therapeutics Announces US FDA Grants an Additional Seven-Year Orphan Drug Exclusivity Period for Nefecon
Earlier Reported, Everest Medicines' Partner Calliditas Therapeutics Announces US FDA Grants an Additional Seven-Year Orphan Drug Exclusivity Period for Nefecon
Everest Medicines (HKEX 1952.HK, "Everest", or the "Company")'s licensing partner Calliditas Therapeutics AB (NASDAQ:CALT, Nasdaq Stockholm: CALTX))))) ("Calliditas") announced that the U.S. FDA has granted an orphan drug exclusivity period of seven years for Nefecon, expiring in December 2030 based on Calliditas obtaining full approval with a new indication for this drug product in December 2023.
珠峯藥業（HKEX 1952.HK，“Everest” 或 “公司”）的許可合作伙伴Calliditas Therapeutics AB（納斯達克股票代碼：CALT，納斯達克斯德哥爾摩股票代碼：CALTX））（“Calliditas”）（“Calliditas”）（“Calliditas”）宣佈，根據Calliditas獲得新適應症的全面批准，美國食品藥品管理局已授予Nefecon的七年孤兒藥獨家經營期，該期限將於2030年12月到期將於 2023 年 12 月購買該藥品。
Following full approval in December 2023, Nefecon is indicated "to reduce the loss of kidney function in adults with primary immunoglobulin A nephropathy (IgAN) who are at risk for disease progression". The exclusivity period reflects the new indication covering all adult patients with primary IgAN at risk of disease progression based on a confirmed reduction of kidney loss reflecting a clinical benefit on kidney function for adult patients with primary IgAN.
在2023年12月獲得全面批准後，Nefecon被指示 “減少有疾病進展風險的原發性免疫球蛋白A腎病（IGaN）成年人的腎功能喪失”。排他期反映了涵蓋所有有疾病進展風險的原發性IgAn的成年患者的新適應症，其依據是已證實的腎臟流失減少反映了原發性IgAn成年患者腎功能的臨床益處。