Global InformationAvalglucosidase alfa information
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| Trade names | Nexviazyme, Nexviadyme |
| Other names | GZ-402666, avalglucosidase alfa-ngpt |
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| Routes of administration | Intravenous |
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| Formula | C4490H6818N1197O1299S32 |
| Molar mass | 99376.93 g·mol−1 |
Avalglucosidase alfa, sold under the brand name Nexviazyme, is an enzyme replacement therapy medication used for the treatment of glycogen storage disease type II (Pompe disease).[6][7]
The most common side effects include headache, fatigue, diarrhea, nausea, joint pain (arthralgia), dizziness, muscle pain (myalgia), itching (pruritus), vomiting, difficulty breathing (dyspnea), skin redness (erythema), feeling of "pins and needles" (paresthesia) and skin welts (urticaria).[7]
Avalglucosidase alfa was approved for medical use in the United States in August 2021,[7][9][10][11] and in the European Union in June 2022.[8]
- ^ a b "Nexviazyme". Therapeutic Goods Administration (TGA). 1 November 2021. Archived from the original on 28 December 2021. Retrieved 28 December 2021.
- ^ "Updates to the Prescribing Medicines in Pregnancy database". Therapeutic Goods Administration (TGA). 12 May 2022. Archived from the original on 3 April 2022. Retrieved 13 May 2022.
- ^ "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.
- ^ "Notice: Multiple Additions to the Prescription Drug List (PDL) [2022-01-24]". Health Canada. 24 January 2022. Archived from the original on 29 May 2022. Retrieved 28 May 2022.
- ^ "Summary Basis of Decision (SBD) for Nexviazyme". Health Canada. 23 October 2014. Archived from the original on 29 May 2022. Retrieved 29 May 2022.
- ^ a b "Nexviazyme ngpt- avalglucosidase alfa injection, powder, lyophilized, for solution". DailyMed. Archived from the original on 12 August 2021. Retrieved 11 August 2021.
- ^ a b c d "FDA Approves New Treatment for Pompe Disease". U.S. Food and Drug Administration (FDA) (Press release). 6 August 2021. Archived from the original on 6 August 2021. Retrieved 6 August 2021.
This article incorporates text from this source, which is in the public domain.
- ^ a b "Nexviadyme EPAR". European Medicines Agency (EMA). 20 July 2021. Archived from the original on 28 July 2022. Retrieved 29 July 2022. Text was copied from this source which is © European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
- ^ "Drug Trials Snapshot: Nexviazyme". U.S. Food and Drug Administration (FDA). 30 May 2023. Retrieved 1 June 2023. This article incorporates text from this source, which is in the public domain.
- ^ "FDA approves Nexviazyme (avalglucosidase alfa-ngpt), an important new treatment option for late-onset Pompe disease" (Press release). Sanofi. 6 August 2021. Archived from the original on 6 August 2021. Retrieved 6 August 2021 – via GlobeNewswire.
- ^ "Drug Approval Package: Nexviazyme". U.S. Food and Drug Administration (FDA). 7 September 2021. Archived from the original on 29 January 2023. Retrieved 1 June 2023.
