idursulfase
idursulfase: developed by 1 company · 5 clinical trials tracked · 1 FDA decision.
idursulfase evidence translation
What we can confirm
1 FDA record · 5 tracked trials
What it means
What to watch
Prepared research question
How could idursulfase → SHPGF affect its developer, and what evidence supports the link?
Traceable citations · Unknowns marked
See linked entities and source evidence2 indications · 2 study sponsors
Development Pipeline (1)
| Company | Phase |
|---|---|
| SHIRE PLC (SHPGF) Hunter Syndrome | Approved |
Clinical Trials (5)
An Open-Label Extension for Subjects in Studies HGT-HIT-046 and SHP609-302 Evaluating Long-Term Safety of Intrathecal Idursulfase-IT Administered in Conjunction With Intravenous Elaprase® in Subjects With Hunter Syndrome and Cognitive Impairment
Primary endpoint: Number of Participants with Adverse Events (AEs) by Type and Severity
An Open-label, Multicenter, Phase 4 Study to Assess the Effects of a Prophylactic Immune Tolerizing Regimen in MPS II Treatment-Naïve Patients Planned to Receive ELAPRASE Who Are at Risk of Developing Persistent Neutralizing Antibodies
Primary endpoint: Rate of Anti-Idursulfase Antibodies Formation, Including Anti-Idursulfase Antibodies That Have Enzyme Neutralizing Activity
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
Primary endpoint: Percent change from baseline in cerebrospinal fluid (CSF) heparan sulfate (HS) concentration (Cohort A)
An Open Label Extension of Study HGT-HIT-094 Evaluating Long Term Safety and Clinical Outcomes of Intrathecal Idursulfase Administered in Conjunction With Elaprase® in Patients With Hunter Syndrome and Cognitive Impairment
Primary endpoint: Number of Participants With Adverse Events (AEs)
An Open-Label Extension of Study HGT-HIT-045 Evaluating Long-Term Safety and Clinical Outcomes of Intrathecal Idursulfase-IT Administered in Conjunction With Intravenous Elaprase® in Pediatric Patients With Hunter Syndrome and Cognitive Impairment
Primary endpoint: Number of Participants With Treatment-emergent Adverse Events (TEAEs)
FDA Decisions1 records
Frequently asked questions
Who is developing idursulfase?
idursulfase is being developed by SHIRE PLC.
How many clinical trials involve idursulfase?
BioSniper tracks 5 clinical trials involving idursulfase.
What is idursulfase's latest FDA decision?
The most recent tracked FDA decision for idursulfase is Approval for 1 INDICATIONS AND USAGE ELAPRASE is indicated for patients with Hunter syndrome (Mucopolysaccharidosis II, MPS II). 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, dated July 24, 2006.