Agalsidase beta
As of the edition of 20 October 2026, Agalsidase beta is an enzyme: marketed, first approved in 2001 (EU); US protection ends in 2028.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2004
- Kind
- Enzyme
- Brand name
- Fabrazyme
- First approved
- 3 August 2001 (EU)
- Approvals on record
- 7 in 4 regions
- Holder of the most recent approval
- JCR Pharmaceuticals; 3 holders in all
- Registered trials
- 23, 4 stopped early
- Disease areas
- Heart and blood vessels; Inherited and neonatal; Nervous system; Nutrition and metabolism; Pregnancy and women's health; Urinary and reproductive
US protection
US protection ends in 2028.
The orphan exclusivity ends in 2028 (it covers one use only). The application that gives this date is held by Sanofi.
This is the US only, and it is not the date generics or biosimilars can enter.
The exact date and the listings behind it
In the product2 listings count towards this date. The exact date and each listing are in the product.
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Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 5 | 4 | 1 | 0 |
| Phase 1 | 1 | 1 | 0 | 0 |
| Phase 2 | 4 | 3 | 0 | 1 |
| Phase 3 | 4 | 3 | 0 | 0 |
| Phase 4 | 9 | 6 | 0 | 3 |
| All trials | 23 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Sanofi | Applicant and Lead sponsor of trials | 1999 to now |
| JCR Pharmaceuticals | Applicant | 2018 to now |