Drugs / Fabrazyme
Regulatory milestones approvals, filings & regulatory actions · 4 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansions (2) | US (FDA) | FABRAZYME | — | 2006-09-29 – 2021-03-11 | fda.gov ↗ |
| Approved | US (FDA) | FABRAZYME | — | 2003-04-24 | fda.gov ↗ |
| Approved | EU (EMA) | Fabrazyme | — | 2001-08-03 | europa.eu ↗ |
Trials 5
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 23 trials | ||||||
| Phase 2 | NCT00196716 | Jun 2003 → Apr 2006 | Fabry disease | Genzyme, a Sanofi Company | Completed | No outcome recorded |
| Phase 2 | NCT00837824 | Dec 2002 → Aug 2003 | Fabry disease, chronic kidney disease | Genzyme, a Sanofi Company | Terminated | No outcome recorded |
| Phase 2 | NCT00074958 | Oct 2002 → May 2005 | Fabry disease | Genzyme, a Sanofi Company | Completed | No outcome recorded |
| Phase 31 trial | ||||||
| Phase 3 | NCT00074971 | Oct 1999 → Dec 2004 | Fabry disease | Genzyme, a Sanofi Company | Completed | No outcome recorded |
| Phase 41 trial | ||||||
| Phase 4 | NCT00312767 | Apr 2006 → ? | Fabry disease | Genzyme, a Sanofi Company | Withdrawn | No outcome recorded |
| Comparator or background therapy3 trials | ||||||
| Phase 1 | NCT05343715 Comparator | Oct 2021 → Mar 2022 | Fabry disease | Bio Sidus SA | Completed | No outcome recorded |
| Phase 1 | NCT02930655 Background | Feb 2015 → Feb 2016 | Fabry disease | Idorsia Pharmaceuticals Ltd. | Completed | No outcome recorded |
| Phase 4 | NCT01997489 Background | Sep 2001 → Sep 2013 | Fabry disease | Rigshospitalet, Denmark | Completed | No outcome recorded |
Evidence & citations 5 cited values
Every value below carries the sentence it was read from. 9 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Fabrazyme | “Fabrazyme” NCT01997489 ↗ |
| Known as | agalsidase beta | “OBJECTIVE: To evaluate the safety and explore the efficacy of enzyme replacement therapy with agalsidase beta (recombinant human alpha-galactosidase A; Fabrazyme [Genzyme...” PMID 18346516 ↗ Dec 20075“Fabrazyme (agalsidase beta) 1 mg/kg” NCT05343715 ↗ “Fabrazyme (agalsidase beta)” NCT00196716 ↗ “Fabrazyme (agalsidase beta)” NCT00837824 ↗ “Fabrazyme (agalsidase beta)” NCT00312767 ↗ “Fabrazyme (agalsidase beta)” NCT00074971 ↗ |
| Action | Restore | “enzyme replacement therapy” PMID 18346516 ↗ Dec 2007 |
| Modality | Protein / enzyme biologic | “enzyme replacement therapy with agalsidase beta (recombinant human alpha-galactosidase A; Fabrazyme [Genzyme Corporation, Cambridge, MA])” PMID 18346516 ↗ Dec 2007 |
| Route | Intravenous | “agalsidase beta (1 mg/kg) was infused intravenously every 2 weeks” PMID 18346516 ↗ Dec 2007 |