CANbridge Pharmaceuticals CAN108 New Drug Application (NDA) for Alagille Syndrome Accepted by China’s National Medical Products Administration
Retrieved on:
星期二, 一月 18, 2022
Education, Health, Research, Science, Pharmaceutical, University, Biotechnology, MPS, New Drug Application, NDA, Research, Patient, Haemophilia, University of Massachusetts, Hunter syndrome, NMPA, Liver, Glioblastoma, Spiroplasma mirum, University of Massachusetts Medical School, Itch, Alagille syndrome, Liver injury, GBM, CEO, Biliary atresia, Jaundice, Hepatomegaly, Genetic distance, Xanthoma, 2-Bromo-LSD, WuXi Biologics, Review, University, University of Washington School of Medicine, Lists of diseases, Frost & Sullivan, IBAT, Primary biliary cholangitis, Excoriation disorder, Heart, Sleep, Disorder, MPS II, Serum, US Foods, Enterohepatic circulation, Glycogen storage disease, Cholestatic pruritus, FDA, Liver disease, PFIC, Pharmaceutical industry, Alagille syndrome (ALGS）, Maralixibat, ALAGILLE SYNDROME (ALGS）, MARALIXIBAT
CANbridge anticipates that the application will be granted priority review, upon the close of the publicity period of the priority review process, on January 17th.
Key Points:
- CANbridge anticipates that the application will be granted priority review, upon the close of the publicity period of the priority review process, on January 17th.
- CANbridge and Mirum Pharmaceuticals signed an exclusive license agreement for the development and commercialization of maralixibat (CAN108) in Greater China last year.
- Under the terms of the agreement, CANbridge has the right to develop and commercialize CAN108 for three indications: Alagille syndrome (ALGS), progressive familial intrahepatic cholestasis (PFIC) and biliary atresia (BA) in Greater China.
- Alagille syndrome (ALGS) is a rare autosomal dominant disorder that affects multiple organs, including the liver, heart, bones and eyes.