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Fabrazyme · 3 trials · 1 indication
Kidney biopsies were taken at Baseline, Week 24, and Week 96 and analyzed for cellular GL-3 accumulation (inclusions) by light microscopy. Each biopsy was evaluated by pathologists for the total number of vessels with GL-3 accumulation on an inclusion severity score of 0 (none/trace), 1 (mild), 2 (moderate), and 3 (severe).
Skin biopsies were taken at Baseline, Week 24 and Week 48 and analyzed for cellular GL-3 accumulation (inclusions) by light microscopy. Each biopsy was evaluated by pathologists for the total number of vessels with GL-3 accumulation on an inclusion severity score of 0 (none/trace), 1 (mild), 2 (moderate), and 3 (severe).
| Arm | Type | Description |
|---|---|---|
| Fabrazyme | EXPERIMENTAL | Open-label study. Patients received 1.0 mg/kg Fabrazyme every two weeks for approximately six months followed by 0.3 mg/kg Fabrazyme every two weeks for approximately 18 months. |
| Name | Type | Description |
|---|---|---|
| Fabrazyme (agalsidase beta) | DRUG | - |
Inclusion Criteria: * Patients must have successfully completed the previous double-blind study (AGAL-1-002-98) * Patients must provide written informed consent prior to study participation * Female patients must have a negative pregnancy test prior to each dosing and use a medically accepted metho...
Fabrazyme is used for Fabry disease, a rare inherited lysosomal storage disorder. It is an investigational monoclonal antibody being developed by Sanofi. The drug has been studied in clinical trials for patients with Fabry disease, including pediatric patients as young as 7 years old.
Fabrazyme is a monoclonal antibody. Its specific molecular target is not disclosed in the available clinical trial information. The drug is being studied for its safety and efficacy in patients with Fabry disease.
Fabrazyme is developed by Sanofi, a global biopharmaceutical company listed on the stock exchange under the ticker SNY. Sanofi is conducting clinical trials to evaluate the drug's safety and efficacy in patients with Fabry disease.
Fabrazyme is in Phase 3 clinical development for Fabry disease. It has completed three clinical trials, including one Phase 3 study and two Phase 2 studies. The drug remains investigational and is not yet approved for commercial use.
Fabrazyme has completed three clinical trials. NCT00074958 was a Phase 2 study in pediatric patients with Fabry disease. NCT00074971 was a Phase 3 study in patients aged 16 years and older. NCT00196716 was a Phase 2 study in male patients with Fabry disease.
Fabrazyme is the brand name for agalsidase beta, an enzyme replacement therapy for Fabry disease. The clinical trials listed under the name Fabrazyme evaluate the safety and efficacy of this treatment in patients with Fabry disease.