Global InformationPegunigalsidase alfa information
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| Trade names | Elfabrio |
| Other names | PRX-102, pegunigalsidase alfa-iwxj |
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| Routes of administration | Intravenous |
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| Formula | C2060H3130N552O601S27 |
| Molar mass | 46110.58 g·mol−1 |
Pegunigalsidase alfa, sold under the brand name Elfabrio, is an enzyme replacement therapy for the treatment of Fabry disease.[2][4] It is a recombinant human α-galactosidase-A.[4] It is a hydrolytic lysosomal neutral glycosphingolipid-specific enzyme.[2]
The most common side effects are infusion-related reactions, hypersensitivity and asthenia.[4]
Pegunigalsidase alfa was approved for medical use in both the European Union and the United States in May 2023.[4][3]
- ^ "FDA-sourced list of all drugs with black box warnings (Use Download Full Results and View Query links.)". nctr-crs.fda.gov. FDA. Retrieved 22 October 2023.
- ^ a b c "Elfabrio- pegunigalsidase alfa injection, solution, concentrate". DailyMed. 23 May 2023. Retrieved 24 May 2023.
- ^ a b "Novel Drug Approvals for 2023". U.S. Food and Drug Administration (FDA). 9 May 2023. Archived from the original on 21 January 2023. Retrieved 12 May 2023.
- ^ a b c d e Cite error: The named reference
Elfabrio EPARwas invoked but never defined (see the help page).