Regulatory news: Avalglucosidase alfa-ngpt (Nexviazyme) for late-onset Pompe disease-FDA approval summary

J Inherit Metab Dis. 2022 Nov;45(6):1015-1017. doi: 10.1002/jimd.12543. Epub 2022 Aug 18.

Authors

Ann R Punnoose¹, Linda J B Jeng¹, Janet W Maynard¹; Review Team

Affiliation

¹ Office of New Drugs, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland, USA.

PMID: 35929375
DOI: 10.1002/jimd.12543

No abstract available

Publication types

Editorial

MeSH terms

Enzyme Replacement Therapy
Glycogen Storage Disease Type II* / drug therapy
Humans
alpha-Glucosidases / therapeutic use

Substances

alpha-Glucosidases