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New AAPS Journal article of possible community interest

  • 1.  New AAPS Journal article of possible community interest

    Posted 01-30-2023 13:02
    Model-Informed Approach Supporting Approval of Nexviazyme (Avalglucosidase Alfa-ngpt) in Pediatric Patients with Late-Onset Pompe Disease - The AAPS Journal
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    Model-Informed Approach Supporting Approval of Nexviazyme (Avalglucosidase Alfa-ngpt) in Pediatric Patients with Late-Onset Pompe Disease - The AAPS Journal
    In August 2021, the US Food and Drug Administration approved Nexviazyme (avalglucosidase alfa-ngpt) for intravenous infusion to treat patients 1 year of age and older with late-onset Pompe disease (LOPD). The effectiveness and safety were studied in patients with LOPD and patients with infantile-onset Pompe disease (IOPD).
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    Ho-Leung Fung Ph.D., FAAPS
    Editor-in-Chief
    University at Buffalo
    Sarasota FL
    [email protected]

    Disclaimer: Opinions expressed are solely my own and do not express the views or opinions of my employer.
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