Brand Name
Elaprase
Generic Name
Idursulfase
View Brand Information FDA approval date: July 24, 2006
Classification: Hydrolytic Lysosomal Glycosaminoglycan-specific Enzyme
Form: Solution
What is Elaprase (Idursulfase)?
ELAPRASE is indicated for patients with Hunter syndrome . ELAPRASE has been shown to improve walking capacity in patients 5 years and older. In patients 16 months to 5 years of age, no data are available to demonstrate improvement in disease-related symptoms or long term clinical outcome; however, treatment with ELAPRASE has reduced spleen volume similarly to that of adults and children 5 years of age and older. The safety and efficacy of ELAPRASE have not been established in pediatric patients less than 16 months of age [see Use in Specific Populations.
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A Phase 2/3, Multicenter, Double-Blind, Randomized Study to Determine the Efficacy and Safety of Tividenofusp Alfa (DNL310) vs Idursulfase in Pediatric and Young Adult Participants With Neuronopathic or Non-Neuronopathic Mucopolysaccharidosis Type II
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