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.
- 欧盟委员会授予LIVMARLI药品治疗3个月及以上PFIC患者的上市授权。
- 批准是在CHMP发布正面意见后进行的，结论是LIVMARLI在PFIC中的临床效益优于现有疗法。
- LIVMARLI还获得了正面的COMP意见，建议在PFIC中保持孤儿药物认定。
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.（纳斯达克：MIRM）今天宣布，欧洲委员会已经授予LIVMARLI（马来酸盐口服溶液）用于治疗PFIC的前进保险患者（三个月及以上的患者）的上市授权。批准是在CHMP做出正面意见后进行的。CHMP认为，与已批准的治疗PFIC的现有疗法相比，LIVMARLI在PFIC中具有显著的临床优势，提高了疗效，对患者护理做出了重大贡献。此外，COMP对LIVMARLI在PFIC中的孤儿药物认定进行了评估，并建议维持认定。