Last reviewed · How we verify
Aldurazyme
At a glance
| Generic name | Aldurazyme |
|---|---|
| Sponsor | Genzyme, a Sanofi Company |
| Modality | Biologic |
| Therapeutic area | Other |
| Phase | FDA-approved |
Approved indications
- Mucopolysaccharidosis, MPS-I
Common side effects
- Infusion reactions
- Rash
- Flushing
- Pyrexia
- Headache
- Abdominal pain or discomfort
- Injection site reaction
- Nausea
- Diarrhea
- Feeling hot or cold
- Vomiting
- Pruritus
Serious adverse events
- Anaphylactic reactions
- Hypersensitivity reactions
- Airway obstruction
- Bronchospasm
- Dyspnea
Key clinical trials
- PEARL (PrEnAtal Enzyme Replacement Therapy for Lysosomal Storage Disorders) (PHASE1)
- Evaluation of Intravenous Laronidase Pharmacokinetics Before and After Hematopoietic Cell Transplantation in Patients With Mucopolysaccharidosis Type IH.
- China Post-marketing Surveillance (PMS) Study of Aldurazyme® (PHASE4)
- Efficacy and Safety of YW17 (Laronidase-CinnaGen) Compared to Aldurazyme® in MPS I Patients (PHASE3)
- A Study of the Effect of Aldurazyme® (Laronidase) Treatment on Lactation in Female Patients With Mucopolysaccharidosis I (MPS I) and Their Breastfed Infants (PHASE4)
- A Study to Assess the Safety of Myozyme® and of Aldurazyme® in Male and Female Participants of Any Age Group With Pompe Disease or With Mucopolysaccharidosis Type I (MPS I) in a Home-care Setting
- Extension Study of Intrathecal Enzyme Replacement for Cognitive Decline in MPS I (NA)
- Administration of IV Laronidase Post Bone Marrow Transplant in Hurler (PHASE1)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |