AQNEURSA
AQNEURSA™ (levacetylleucine) is indicated for the treatment of neurological manifestations of Niemann-Pick disease type C (NPC) in adults and pediatric patients weighing ≥15 kg.
AQNEURSA is the only FDA-approved stand-alone therapy for the treatment of NPC and is available now.
For more information visit aqneursa.com
AQNEURSA Cares Program Information
Latest News
U.S. FDA approves AQNEURSA™ (IB1001) for the Treatment of NPC
IntraBio is pleased to share the U.S. Food and Drug Administration (FDA) has approved has AQNEURSA™ for the treatment of neurological manifestations of Niemann-Pick disease type C (NPC) in adults and pediatric patients weighing ≥15 kg.
Read IntraBio Letter to the NPC Community
Read IntraBio Press Release
Read FDA Press Release
09/25/2024
Update from IntraBio: IntraBio is pleased to announce that the U.S. Food and Drug Administration (FDA) has accepted its New Drug Application (NDA) for IB1001 for the treatment of Niemann-Pick disease Type C (NPC). The application has been granted Priority Review and was given a Prescription Drug User Fee Act (PDUFA) target action date of September 24th, 2024.
Read the complete announcement.