Journal of Inherited Metabolic DiseaseAccepted Articles EDITORIALFree Access Regulatory News: Avalglucosidase alfa-ngpt (Nexviazyme) for Late-onset Pompe Disease: FDA Approval Summary Ann R. Punnoose, Corresponding Author Ann R. Punnoose [email protected] Office of New Drugs, Office of Biostatistics, Office of Clinical Pharmacology, Office of Pharmaceutical Quality, Office of Biotechnology Products, Office of New Drug Products, Office of Pharmaceutical Manufacturing Assessment, Center for Drug Evaluation and Research, U.S. Food and Drug Administration Correspondence Ann R Punnoose, Office of New Drugs, Center for Drug Evaluation and Research, 10903 New Hampshire Ave, Silver Spring, MD 20903, USA Email: [email protected] for more papers by this authorLinda J. B. Jeng, Linda J. B. Jeng Office of New Drugs, Office of Biostatistics, Office of Clinical Pharmacology, Office of Pharmaceutical Quality, Office of Biotechnology Products, Office of New Drug Products, Office of Pharmaceutical Manufacturing Assessment, Center for Drug Evaluation and Research, U.S. Food and Drug AdministrationSearch for more papers by this authorJanet W. Maynard, Janet W. Maynard Office of New Drugs, Office of Biostatistics, Office of Clinical Pharmacology, Office of Pharmaceutical Quality, Office of Biotechnology Products, Office of New Drug Products, Office of Pharmaceutical Manufacturing Assessment, Center for Drug Evaluation and Research, U.S. Food and Drug AdministrationSearch for more papers by this authorthe Review Team, the Review TeamSearch for more papers by this author Ann R. Punnoose, Corresponding Author Ann R. Punnoose [email protected] Office of New Drugs, Office of Biostatistics, Office of Clinical Pharmacology, Office of Pharmaceutical Quality, Office of Biotechnology Products, Office of New Drug Products, Office of Pharmaceutical Manufacturing Assessment, Center for Drug Evaluation and Research, U.S. Food and Drug Administration Correspondence Ann R Punnoose, Office of New Drugs, Center for Drug Evaluation and Research, 10903 New Hampshire Ave, Silver Spring, MD 20903, USA Email: [email protected] for more papers by this authorLinda J. B. Jeng, Linda J. B. Jeng Office of New Drugs, Office of Biostatistics, Office of Clinical Pharmacology, Office of Pharmaceutical Quality, Office of Biotechnology Products, Office of New Drug Products, Office of Pharmaceutical Manufacturing Assessment, Center for Drug Evaluation and Research, U.S. Food and Drug AdministrationSearch for more papers by this authorJanet W. Maynard, Janet W. Maynard Office of New Drugs, Office of Biostatistics, Office of Clinical Pharmacology, Office of Pharmaceutical Quality, Office of Biotechnology Products, Office of New Drug Products, Office of Pharmaceutical Manufacturing Assessment, Center for Drug Evaluation and Research, U.S. Food and Drug AdministrationSearch for more papers by this authorthe Review Team, the Review TeamSearch for more papers by this author First published: 05 August 2022 https://doi.org/10.1002/jimd.12543 This article has been accepted for publication and undergone full peer review but has not been through the copyediting, typesetting, pagination and proofreading process, which may lead to differences between this version and the Version of Record. Please cite this article as doi: 10.1002/jimd.12543. AboutPDF ToolsExport citationAdd to favoritesTrack citation ShareShare Give accessShare full text accessShare full-text accessPlease review our Terms and Conditions of Use and check box below to share full-text version of article.I have read and accept the Wiley Online Library Terms and Conditions of UseShareable LinkUse the link below to share a full-text version of this article with your friends and colleagues. Learn more.Copy URL Share a linkShare onFacebookTwitterLinked InRedditWechat Accepted ArticlesAccepted, unedited articles published online and citable. The final edited and typeset version of record will appear in the future. RelatedInformation