Drugs / agalsidase beta
agalsidase beta
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 13
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT05343715 | Oct 2021 → Mar 2022 | Fabry disease | Bio Sidus SA | Completed | No outcome recorded |
| Phase 21 trial | ||||||
| Phase 2 | NCT01196871 | Feb 2011 → Oct 2012 | Fabry disease | Amicus Therapeutics | Completed | No outcome recorded |
| Phase 33 trials | ||||||
| Phase 3 | NCT06081062 | Apr 2023 → Jun 2025 overdue | Fabry disease | ISU Abxis Co., Ltd. | Recruiting | No outcome recorded |
| Phase 3 | NCT05843916 | Dec 2022 → Sep 2024 | Fabry disease | Bio Sidus SA | Completed | No outcome recorded |
| Phase 3 | NCT00701415 | Sep 2008 → Jun 2015 | Fabry disease | Genzyme, a Sanofi Company | Completed | No outcome recorded |
| Phase 48 trials | ||||||
| Phase 4 | NCT06019728 | Nov 2023 → Oct 2024 | Fabry disease | Sanofi | Completed | No outcome recorded |
| Phase 4 | NCT05054387 | Oct 2021 → Mar 2023 | Fabry disease | Genzyme, a Sanofi Company | Completed | No outcome recorded |
| Phase 4 | NCT04143958 | Sep 2020 → Nov 2023 | Fabry disease | Sanofi | Withdrawn | No outcome recorded Stop: Enrollment |
| Phase 4 | NCT01650779 | Apr 2012 → Mar 2013 | Fabry disease | Genzyme, a Sanofi Company | Completed | No outcome recorded |
| Phase 4 | NCT00230607 | May 2006 → Feb 2024 | Fabry disease | Genzyme, a Sanofi Company | Terminated | No outcome recorded |
| Phase 4 | NCT00140621 | Jul 2005 → Aug 2012 | Fabry disease | Genzyme, a Sanofi Company | Completed | No outcome recorded |
| Phase 4 | NCT00487630 | Jun 2005 → Jun 2009 | Fabry disease | Assistance Publique - Hôpitaux de Paris | Unknown | No outcome recorded |
| Phase 4 | NCT00081497 | Jan 2004 → Sep 2005 | Fabry disease | Genzyme, a Sanofi Company | Completed | No outcome recorded |
| Comparator or background therapy4 trials | ||||||
| Phase 3 | NCT05280548 Comparator | May 2022 → May 2026 overdue | Fabry disease | Sanofi | Active not recruiting | No outcome recorded |
| Phase 3 | NCT02795676 Comparator | Jun 2016 → Oct 2021 | Fabry disease | Protalix | Completed | Met primary |
| Phase 3 | NCT01218659 Comparator | Sep 2011 → May 2014 | Fabry disease | Amicus Therapeutics | Completed | No outcome recorded |
| Phase 4 | NCT00074984 Comparator | Feb 2001 → Jan 2004 | Fabry disease | Genzyme, a Sanofi Company | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 5
| Date | Issuer | Release |
|---|---|---|
| 2024-12-13 | NPO Petrovax | Regulatory Russia completes first time ever localization of an orphan drug, including biosynthesis of its drug substance petrovax.com ↗
Petrovax Pharm reports to have completed authorization procedures for the drug Fabagal ® (agalsidase beta) manufactured locally (full-cycle production) and used to treat Fabry disease [ 1 ] . |
| 2024-06-26 | NPO Petrovax | Results Twenty years to make a diagnosis: how specialists identify and treat patients with Fabry disease in Russia? petrovax.com ↗
The test drug has shown there comparable pharmacokinetics and a similar level of safety. |
| 2023-08-21 | NPO Petrovax | Regulatory The rare Fabry disease treatment Fabagal has received the market approval in Russia petrovax.com ↗
Biotechnological company Petrovax received a market approval [ 1 ] [ 2 ] , for the first biosimilar of agalsidase beta in Russia — Fabagal aimed to treat adults and children from 8 years old with a rare Fabry disease. |
| 2021-02-02 | Sanofi | Results 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 ↗
Stabilization of kidney function decline and cardiomyopathy in male patients with classic Fabry disease: a pre- vs. post-agalsidase beta treatment Fabry Registry analysis |
| 2018-05-25 | Protalix | Results Protalix BioTherapeutics Announces Poster Presentation on Baseline Characteristics for Fabry Disease Patients Screened in the Phase III BALANCE Study of Pegunigalsidase Alfa at the 55th ERA-EDTA Congress protalix.com ↗
The results demonstrate that 15 out of 27 screened male patients were ADA positive and, of those, all 15 had neutralizing antibodies to Fabrazyme |
All press releases naming this drug 7 releases
Evidence & citations 7 cited values
Every value below carries the sentence it was read from. 18 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Agalsidase beta | “Clearance of Gb3 and stabilization of renal function has been demonstrated in male patients treated with agalsidase beta (FABRAZYME).” NCT00487630 ↗ |
| Known as | agalsidase beta; Fabrazyme | “agalsidase beta; Fabrazyme” NCT01218659 ↗ |
| Known as | Fabagal | “Fabagal® (Agalsidase beta)” NCT06081062 ↗ |
| Known as | Fabrazyme | “Clearance of Gb3 and stabilization of renal function has been demonstrated in male patients treated with agalsidase beta (FABRAZYME).” NCT00487630 ↗1“Fabrazyme (agalsidase beta) 1 mg/kg” NCT05343715 ↗ |
| Known as | GZ419828 | “Drug: agalsidase beta (GZ419828)” NCT04143958 ↗1“Agalsidase beta (GZ419828)” NCT05280548 ↗ |
| Modality | Protein / enzyme biologic | “α-galactosidase A (R-h α-GAL) Replacement Therapy” NCT00140621 ↗ |
| Route | Intravenous | “Intravenous infusion of agalsidase beta (1 mg per kg of body weight) or placebo every 2 weeks” PMID 17179052 ↗ Dec 2006 |