CANbridge Reports NMPA Acceptance of NDA for AN108 to Treat Alagille Syndrome
Shots:
- The NMPA has accepted the NDA for CAN108 for cholestatic pruritus in patients aged ≥1yr. with ALGS. Additionally, priority review is expected to be granted, upon closure of the priority review process
- CANbridge entered into an exclusive license agreement with Mirum to develop & commercialize maralixibat in Greater China where CANbridge obtains the right to develop & commercialize CAN108 for 3 indications: ALGS, PFIC & BA in Greater China
- Livmarli is an IBAT inhibitor & is 1st FDA-approved therapy for cholestatic pruritus associated with ALGS. The therapy is being evaluated in a P-III trial for PFIC in North America, EU, Asia, & South America while P-IIb (EMBARK) trial for BA is underway
Ref: Businesswire | Image: Businesswire
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