IntraBio Announces U.S. FDA Accepts New Drug Application for IB1001 for the Treatment of Niemann-Pick disease type C
Read the full announcement from IntraBio here:
IntraBio has announced that the U.S. FDA has accepted its New Drug Application (NDA) for IB1001 for the treatment of Niemann-Pick disease Type C (NPC). The NDA for IB1001 has been granted Priority Review with a PDUFA target action date set for September 24, 2024.
The application is based on positive results from the IB1001-301 Phase 3 Pivotal Trial, which demonstrated improvement in neurological signs and symptoms, functioning, and quality of life in adult and pediatric patients with NPC.
The NDA also includes data from a multinational Phase IIb trial showing improvements in symptoms and quality of life in NPC patients. If approved, IB1001 is expected to address the high unmet medical need for NPC patients.
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