International Niemann–Pick Disease Alliance

Updates

  1. Zevra NPC Community Letter – MIPLYFFA now available (USA)

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  2. IntraBio Announces U.S. FDA Approval of AQNEURSA for the Treatment of Niemann- Pick Disease Type C

    • AQNEURSA™ (ak-nur-sah) is the only FDA-approved stand-alone therapy for the treatment of Niemann-Pick disease type C (NPC) • Approval follows positive Phase III data demonstrating significant improvements in neurological symptoms and functional benefits that could be seen within...

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  3. GeMDAC Votes Favorably on Arimoclomol for NPC: Key Step Toward FDA Approval

          August 2nd, 2024 Dear NPC Community, Today, the Genetic Metabolic Diseases Advisory Committee (GeMDAC) met to review Zevra Therapeutics’ arimoclomol as an orally delivered treatment for Niemann-Pick disease type C (NPC). The committee, an independent panel...

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  4. Azafaros announces positive topline Phase 2 study data with nizubaglustat

    Azafaros announces positive topline Phase 2 study data with nizubaglustat in GM2 gangliosidosis and Niemann-Pick disease type C. Study primary endpoint met, with confirmed safety profile Investigators and Patient Organisations supportive of continued development Leiden, The Netherlands, 19 June...

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  5. Azafaros: Completion of 12-week Phase 2 RAINBOW study evaluating lead asset nizubaglustat in rare disease patients

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  6. Pfrieger’s Digest – 02/2024 Edition

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  7. Zevra Therapeutics: FDA Extends Review Period for Arimoclomol NDA

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  8. IntraBio: NEJM Publishes Expert Perspective Editoral on IB1001

    IntraBio Inc is pleased to announce that The New England Journal of Medicine (NEJM) has published a Science Behind the Study Expert Perspective Editorial: N-Acetyl-l-Leucine and Neurodegenerative Disease. The Editorial reports on the broad potential of N-acetyl-L-leucine (IB1001) as...

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  9. NEJM publishes IB1001-301 Trial Results

    IntraBio Inc is pleased to announce that The New England Journal of Medicine (NEJM) has published the detailed results of the Phase 3, Pivotal Trial with N-acetyl-L-leucine (IB1001) for the treatment of Niemann-Pick disease Type C (NPC). New England...

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  10. Azafaros’ Phase 2 RAINBOW study, evaluating nizubaglustat in GM2 and NPC patients, is now fully enrolled

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