Mirum Pharmaceuticals' LIVMARLI Approved In The EU For Patients With PFIC In Patients 3-Months Of Age And Older
Mirum Pharmaceuticals' LIVMARLI Approved In The EU For Patients With PFIC In Patients 3-Months Of Age And Older
- European Commission grants LIVMARLI marketing authorization for treatment of PFIC in patients three months and older.
- Approval follows positive opinion from CHMP concluding LIVMARLI's clinical benefit over existing therapy in PFIC.
- LIVMARLI also received positive COMP opinion recommending maintenance of Orphan Drug Designation in PFIC.
- 歐盟委員會授予LIVMARLI藥品治療3個月及以上PFIC患者的上市授權。
- 批准是在CHMP發佈正面意見後進行的，結論是LIVMARLI在PFIC中的臨床效益優於現有療法。
- LIVMARLI還獲得了正面的COMP意見，建議在PFIC中保持孤兒藥物認定。
Mirum Pharmaceuticals, Inc. (NASDAQ:MIRM) today announced that the European Commission has granted marketing authorization for LIVMARLI (maralixibat) oral solution for the treatment of progressive familial intrahepatic cholestasis (PFIC) in patients three months of age and older. The approval follows a positive opinion by the CHMP which concluded that LIVMARLI in PFIC brings significant clinical benefit based on improved efficacy and a major contribution to patient care compared to the existing approved treatment for PFIC. Further, evaluation by COMP recommended maintenance of Orphan Drug Designation for LIVMARLI in PFIC.
Mirum Pharmaceuticals，Inc.（納斯達克：MIRM）今天宣佈，歐洲委員會已經授予LIVMARLI（馬來酸鹽口服溶液）用於治療PFIC的前進保險患者（三個月及以上的患者）的上市授權。批准是在CHMP做出正面意見後進行的。CHMP認爲，與已批准的治療PFIC的現有療法相比，LIVMARLI在PFIC中具有顯著的臨床優勢，提高了療效，對患者護理做出了重大貢獻。此外，COMP對LIVMARLI在PFIC中的孤兒藥物認定進行了評估，並建議維持認定。