Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
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 an investigational drug being studied for the treatment of Mucopolysaccharidosis I, a rare genetic disorder. It is also known as Aldurazyme and is being developed by Sanofi. The drug is currently in Phase 3 clinical development, meaning it has not yet been approved by regulatory authorities.
rhIDU is a monoclonal antibody, but its specific molecular target has not been disclosed. It is being studied for its potential to treat Mucopolysaccharidosis I, a condition caused by deficiencies in enzymes that break down certain sugars in the body. The drug's mechanism of action is not fully described in available information.
rhIDU is being developed by Sanofi, a multinational pharmaceutical company listed on the stock exchange under the ticker symbol SNY. Sanofi is conducting clinical trials to evaluate the safety and efficacy of rhIDU for the treatment of Mucopolysaccharidosis I.
rhIDU is currently in Phase 3 clinical development. It is an investigational drug, meaning it has not been approved by regulatory agencies such as the FDA. The Phase 3 trial for rhIDU has been completed, and the drug is still undergoing evaluation for its potential use in treating Mucopolysaccharidosis I.
rhIDU has been studied in one clinical trial with the identifier NCT00912925. This Phase 3 trial, titled 'Clinical Study of Aldurazyme in Patients With Mucopolysaccharidosis (MPS) I,' was completed and enrolled 45 participants. The study was conducted in the United States, Canada, and Germany, and included patients aged 5 years and older.
Yes, rhIDU is also known as Aldurazyme. The clinical trial for rhIDU, identified as NCT00912925, is titled 'Clinical Study of Aldurazyme in Patients With Mucopolysaccharidosis (MPS) I,' confirming that the two names refer to the same drug. This drug is being developed by Sanofi for the treatment of Mucopolysaccharidosis I.