Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as rhIDU (recombinant human-Alpha-L-Iduronidase)
rhIDU · 1 trial · 3 indications
Percent Predicted Forced Vital Capacity (FVC): the maximal exhaled breathe volume following a maximal inhaled breath. Overall Change from Baseline to Week 26 in percent predicted FVC = (observed value)/(predicted value) \* 100%). A higher value indicates a greater response.
Six Minute Walk Test (6MWT): Distance walked (measured in meters) in 6 minutes. A longer distance indicates a greater response.
| Arm | Type | Description |
|---|---|---|
| Placebo | PLACEBO_COMPARATOR | Patients in the placebo-control group were administered a solution of 100 millimolar (mM) sodium phosphate, 150 mM sodium chloride, and 0.001% polysorbate-80, adjusted to a pH of 5.8 administered intravenously over approximately 4 hours once weekly for 26 weeks. |
| Aldurazyme treatment | ACTIVE_COMPARATOR | Patients in the active treatment group received Aldurazyme intravenously at a dose of 100 Units/kg (approximately 0.58 mg/kg = labeled dose) administered intravenously over approximately 4 hours once weekly for 26 weeks. |
| Name | Type | Description |
|---|---|---|
| rhIDU (recombinant human-Alpha-L-Iduronidase) | BIOLOGICAL | Patients in the active treatment group received Aldurazyme intravenously at a dose of 100 units/kg (approximately 0.58mg/kg) administered intravenously over approximately 4 hours once weekly for 26 weeks. |
| Placebo | BIOLOGICAL | Patients in the Placebo-control group were administered a solution of 100mM sodium phosphate , 150mM sodium chloride, and 0.001% polysorbate-80, adjusted to a pH of 5.8 administered intravenously over a time period of approximately 4 hours once weekly for 26 weeks. |
Inclusion Criteria: * The patient had a documented diagnosis of MPS I confirmed by measurable clinical signs and symptoms of MPS I and a fibroblast or leukocyte alpha-L-iduronidase enzyme activity level of less than 10% of the lower limit of the normal range of the measuring laboratory. * Female pa...
rhIDU is being developed for the treatment of Mucopolysaccharidosis I, a rare inherited lysosomal storage disorder that includes Hurler syndrome and Hurler-Scheie syndrome. It is an investigational therapy in Phase 3 clinical development and is not yet approved for commercial use.
rhIDU is being developed by Sanofi, which trades on the New York Stock Exchange under the ticker SNY. Sanofi is the sponsor of the clinical program evaluating rhIDU in patients with Mucopolysaccharidosis I.
rhIDU is in Phase 3 clinical development. The program includes one completed Phase 3 trial, and there are currently no active trials listed. rhIDU remains investigational and has not been approved by the FDA for any indication.
rhIDU has been evaluated in one Phase 3 clinical trial, NCT00912925, titled Clinical Study of Aldurazyme in Patients With Mucopolysaccharidosis (MPS) I. The trial enrolled 45 participants across the United States, Canada, and Germany and has been completed.
Yes, rhIDU is also known as recombinant human-Alpha-L-Iduronidase. The abbreviation rhIDU stands for recombinant human-Alpha-L-Iduronidase, and both names refer to the same investigational therapy being developed by Sanofi for Mucopolysaccharidosis I.
The Phase 3 trial NCT00912925 was a randomized, double-blind, placebo-controlled study evaluating rhIDU in patients with Mucopolysaccharidosis I. It enrolled 45 participants aged 5 years and older, including both males and females, and did not enroll healthy volunteers.