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.
珠峰药业（HKEX 1952.HK，“Everest” 或 “公司”）的许可合作伙伴Calliditas Therapeutics AB（纳斯达克股票代码：CALT，纳斯达克斯德哥尔摩股票代码：CALTX））（“Calliditas”）（“Calliditas”）（“Calliditas”）宣布，根据Calliditas获得新适应症的全面批准，美国食品药品管理局已授予Nefecon的七年孤儿药独家经营期，该期限将于2030年12月到期将于 2023 年 12 月购买该药品。
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月获得全面批准后，Nefecon被指示 “减少有疾病进展风险的原发性免疫球蛋白A肾病（IGaN）成年人的肾功能丧失”。排他期反映了涵盖所有有疾病进展风险的原发性IgAn的成年患者的新适应症，其依据是已证实的肾脏流失减少反映了原发性IgAn成年患者肾功能的临床益处。