Drugs / Avalglucosidase alfa
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | EU (EMA) | Nexviadyme | — | 2022-06-24 | europa.eu ↗ |
Trials 9 · a red edge is where a trial was stopped
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT01898364 | Aug 2013 → Feb 2015 | glycogen storage disease II | Genzyme, a Sanofi Company | Completed | No outcome recorded |
| Phase 23 trials | ||||||
| Phase 2 | NCT03019406 | Oct 2017 → Sep 2019 overdue | glycogen storage disease due to acid maltase deficiency, infantile onset | Genzyme, a Sanofi Company | Active not recruiting | No outcome recorded |
| Phase 2 | NCT02032524 | Feb 2014 → Dec 2022 | glycogen storage disease II | Genzyme, a Sanofi Company | Completed | No outcome recorded |
| Phase 2 | NCT00025896 | May 2001 → Sep 2002 | glycogen storage disease due to acid maltase deficiency, infantile onset | Genzyme, a Sanofi Company | Completed | No outcome recorded |
| Phase 32 trials | ||||||
| Phase 3 | NCT04910776 | Sep 2021 → Mar 2026 overdue | glycogen storage disease II | Sanofi | Active not recruiting | No outcome recorded |
| Phase 3 | NCT02782741 | Nov 2016 → Mar 2020 | glycogen storage disease due to acid maltase deficiency, late-onset | Genzyme, a Sanofi Company | Completed | No outcome recorded |
| Phase 43 trials | ||||||
| Phase 4 | NCT06666413 | May 2025 → May 2028 expected | glycogen storage disease II | Genzyme, a Sanofi Company | Recruiting | No outcome recorded |
| Phase 4 | NCT07652814 | Oct 2022 → Mar 2028 expected | glycogen storage disease due to acid maltase deficiency, late-onset | Iris Plug | Active not recruiting | No outcome recorded |
| Phase 4 | NCT05164055 | Jul 2022 → Sep 2026 expected | glycogen storage disease II | Genzyme, a Sanofi Company | Active not recruiting | No outcome recorded |
Press releases naming this drug 11 releases
| Date | Issuer | Release |
|---|---|---|
| 2023-10-06 | Sanofi | Media Update: New data at WMS 2023 reaffirm long-term efficacy of Nexviazyme® (avalglucosidase alfa) for the treatment of Pompe disease sanofi.com ↗ |
| 2023-02-24 | Sanofi | Press release: New Phase 3 data presented at WORLDSymposium™ reinforce Nexviazyme® (avalglucosidase alfa) as potential new standard of care for all people living with late-onset Pompe disease sanofi.com ↗ |
| 2022-06-28 | Sanofi | Press Release: Nexviadyme® (avalglucosidase alfa) approved by European Commission as a potential new standard of care for the treatment of Pompe Disease sanofi.com ↗ |
| 2022-02-08 | Sanofi | Nexviazyme® (avalglucosidase alfa) shows sustained improvements in respiratory function and mobility in patients with Pompe disease sanofi.com ↗ |
| 2021-11-12 | Sanofi | Sanofi announces results of CHMP re-examination of the New Active Substance status for avalglucosidase alfa, a potential new standard of care for the treatment of Pompe disease sanofi.com ↗ |
| 2021-08-06 | Sanofi | FDA approves Nexviazyme® (avalglucosidase alfa-ngpt), an important new treatment option for late-onset Pompe disease sanofi.com ↗ |
| 2021-07-27 | Sanofi | Sanofi provides update on avalglucosidase alfa EU submission for patients with Pompe Disease sanofi.com ↗ |
| 2021-02-02 | Sanofi | Media Update: Data presented at WORLDSymposiumTM reinforces robust rare disease pipeline and highlights additional clinical data for investigational avalglucosidase alfa in Pompe disease sanofi.com ↗ |
| 2020-11-18 | Sanofi | FDA grants priority review for avalglucosidase alfa, a potential new therapy for Pompe disease sanofi.com ↗ |
| 2020-10-02 | Sanofi | EMA accepts regulatory submission for avalglucosidase alfa, a potentially new standard of care enzyme replacement therapy for Pompe disease sanofi.com ↗ |
| 2020-06-08 | Sanofi | Sanofi to present Phase 3 results of avalglucosidase alfa in patients with late-onset Pompe disease sanofi.com ↗ |
Evidence & citations 8 cited values
Every value below carries the sentence it was read from. 11 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Avalglucosidase alfa | “Avalglucosidase alfa, a recombinant human GAA enzyme replacement therapy designed for increased cellular uptake and glycogen clearance, has been studied for long-term efficacy...” PMID 35618441 ↗ Aug 2022 |
| Known as | GZ402666 | “A Phase 3 Randomized, Multicenter, Multinational, Double-blinded Study Comparing the Efficacy and Safety of Repeated Biweekly Infusions of Avalglucosidase Alfa (neoGAA,...” NCT02782741 ↗ |
| Known as | neoGAA | “A Phase 3 Randomized, Multicenter, Multinational, Double-blinded Study Comparing the Efficacy and Safety of Repeated Biweekly Infusions of Avalglucosidase Alfa (neoGAA,...” NCT02782741 ↗ |
| Known as | recombinant human acid alpha-glucosidase | ClinicalTrials.gov intervention name — accepted as the source's own label NCT00025896 ↗ |
| Known as | rhGAA | “recombinant human acid alpha-glucosidase (rhGAA) as a potential enzyme replacement therapy for Pompe disease.” NCT00025896 ↗ |
| Modality | Protein / enzyme biologic | “Enzyme replacement therapy with recombinant human GAA (rhGAA)” PMID 19775921 ↗ Jan 2010 |
| Route | Intravenous | “treated with IV rhGAA” PMID 19775921 ↗ Jan 2010 |
| Target | GAA | “Avalglucosidase alfa, a recombinant human GAA enzyme replacement therapy designed for increased cellular uptake and glycogen clearance” PMID 35618441 ↗ Aug 2022 |