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Aldurazyme (Laronidase) - Summary



ALDURAZYME® (laronidase) is a polymorphic variant of the human enzyme, (alpha)-L-iduronidase that is produced by recombinant DNA technology in a Chinese hamster ovary cell line. (alpha)-L-iduronidase (glycosaminoglycan (alpha)-L-iduronohydrolase, EC is a lysosomal hydrolase that catalyses the hydrolysis of terminal (alpha)-L-iduronic acid residues of dermatan sulfate and heparan sulfate.

ALDURAZYME is indicated for patients with Hurler and Hurler-Scheie forms of Mucopolysaccharidosis I (MPS I) and for patients with the Scheie form who have moderate to severe symptoms. The risks and benefits of treating mildly affected patients with the Scheie form have not been established.

ALDURAZYME has been shown to improve pulmonary function and walking capacity. ALDURAZYME has not been evaluated for effects on the central nervous system manifestations of the disorder.

See all Aldurazyme indications & dosage >>


Published Studies Related to Aldurazyme (Laronidase)

Enzyme replacement therapy with laronidase (Aldurazyme(®)) for treating mucopolysaccharidosis type I. [2013]
CONCLUSIONS: The current evidence demonstrates that laronidase is

Enzyme replacement therapy with laronidase (Aldurazyme) for treating mucopolysaccharidosis type I. [2013]
CONCLUSIONS: The current evidence demonstrates that laronidase is

A dose-optimization trial of laronidase (Aldurazyme) in patients with mucopolysaccharidosis I. [2009.01]
Recombinant human alpha-l-iduronidase (Aldurazyme), laronidase) is approved as an enzyme replacement therapy to treat the lysosomal storage disorder, mucopolysaccharidosis type I (MPS I) at a dose of 0.58 mg/kg by once-weekly intravenous infusion. To assess whether alternate dosing regimens might provide a better reduction in lysosomal storage, a 26-week, randomized, open-label, multinational dose-optimization trial was conducted...

Long-term efficacy and safety of laronidase in the treatment of mucopolysaccharidosis I. [2009.01]
OBJECTIVE: Our goal was to evaluate the long-term safety and efficacy of recombinant human alpha-l-iduronidase (laronidase) in patients with mucopolysaccharidosis I... CONCLUSIONS: This trial demonstrates the long-term clinical benefit and safety of laronidase in attenuated patients with mucopolysaccharidosis I and highlights the magnitude and chronology of treatment effects. Prompt diagnosis and early treatment will maximize treatment outcomes.

Laronidase for treating mucopolysaccharidosis type I. [2007.09.30]
Mucopolysaccharidoses are a group of inherited metabolic diseases caused by the absence or deficiency of the lysosomal enzymes that are needed for breaking down glycosaminoglycans (GAGs).Laronidase seems to be a promising agent for treating mucopolysaccharidosis type I, as shown by the reduction in the urinary excretion of GAGs and the associated improvements in vital capacity and in the performance of defined physical tasks.

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Clinical Trials Related to Aldurazyme (Laronidase)

Phase 3 Extension Study of the Safety and Efficacy of Aldurazyme´┐Ż (Laronidase) in Mucopolysaccharidosis I (MPS I) Patients [Completed]
This study is being conducted to collect additional long-term efficacy and safety data of Aldurazyme« (laronidase) patients with MPS I disease. Patients who were previously enrolled in the Phase 3 Double-Blind Study will be enrolled in this study.

A Study Evaluating the Safety and Pharmacokinetics of Aldurazyme« (Laronidase) in MPS I Patients Less Than 5 Years Old [Completed]
The main objectives of this study are to evaluate the safety and pharmacokinetics (PK) of enzyme replacement therapy with recombinant human alpha-L-iduronidase [Aldurazyme« (laronidase)] in mucopolysaccharidosis I (MPS I) patients less than 5 years old. Efficacy measurements will also be evaluated in this study.

Stem Cell Transplant w/Laronidase for Hurler [Completed]
The investigators hypothesize that weekly infusions of Laronidase ERT for 10-12 weeks prior to transplant and 8 weeks following transplant will result in a reduction of glycosaminoglycans (GAG) burden that is associated with decreased complications following transplant.

Immune Tolerance Study With Aldurazyme« (Laronidase) [Completed]
The purpose of this study is to see if treatment with an antigen-specific immunosuppressive can decrease or stop an antibody response to laronidase (Aldurazyme«) during enzyme replacement therapy with laronidase in severe Mucopolysaccharidosis I (MPS I) participants.

A Dose-optimization Study of Aldurazyme« (Laronidase) in Patients With Mucopolysaccharidosis I (MPS I) Disease [Completed]
The main purpose of this study is to evaluate differences in the pharmacodynamic response of 4 Aldurazyme« (laronidase) dose regimens in patients with Mucopolysaccharidosis I (MPS I).

more trials >>

Reports of Suspected Aldurazyme (Laronidase) Side Effects

Dyspnoea (10)Asthma (8)Respiratory Disorder (8)Spinal Cord Compression (7)Infusion Related Reaction (7)Pyrexia (6)Cyanosis (6)Vomiting (6)Device Related Infection (5)Pallor (5)more >>

Page last updated: 2014-11-30

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