Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
GA/mL · 1 trial · 1 indication
Injection-related (IR) adverse events refers to all local injection site reactions and/or symptoms or events related to immediate post injection reaction (flushing, chest pain, palpitations, anxiety, dyspnea, throat constriction, and/or urticaria). Rate was calculated as # IR events/the total exposure to study drug in years. For cases in which more than 1 IR adverse event started on the same date for the same patient, these were counted as 1 IR adverse event for that patient. Parameter statistics were generated from a Poisson regression model with natural log of treatment duration (years) as an offset variable, and adjusted for baseline EDSS score, treatment group, age, sex, number of relapses in the 2 years prior to screening, in which a contrast comparing treatment groups were constructed. Adjusted mean estimates were adjusted estimates of event rates within treatment group.
Injection-related (IR) adverse events refers to all local injection site reactions and/or symptoms or events related to immediate post injection reaction (flushing, chest pain, palpitations, anxiety, dyspnea, throat constriction, and/or urticaria). Rate was calculated as # IR events/the total exposure to study drug in years. For cases in which more than 1 IR adverse event started on the same date for the same patient, these were counted as 1 IR adverse event for that patient.
Injection-related (IR) adverse events refers to all local injection site reactions and/or symptoms or events related to immediate post injection reaction (flushing, chest pain, palpitations, anxiety, dyspnea, throat constriction, and/or urticaria).
| Arm | Type | Description |
|---|---|---|
| GA 20 mg/mL every day | ACTIVE_COMPARATOR | Glatiramer acetate (GA) 20 mg in 1 mL SC injection administered every day (QD) for the 4 months of the core study. |
| GA 40 mg/mL 3 times a week | EXPERIMENTAL | Glatiramer acetate (GA) 40 mg in 1 mL SC injection administered three times a week (TIW) for the 4 months of the core study. During the Extension period, all participants to continue treatment with GA 40 mg/mL TIW until this dose regimen is commercially available for the treatment of RRMS patients. |
| Name | Type | Description |
|---|---|---|
| GA 20 mg/mL | DRUG | Glatiramer acetate (GA) 20 mg/mL subcutaneous (SC) injection, the commercial product, is a single-use pre-filled syringe (PFS) containing 1.0 ml of a clear, colorless to slightly yellow, sterile, non-pyrogenic solution. |
| GA 40 mg/mL | DRUG | Glatiramer acetate (GA) 40 mg/mL subcutaneous (SC) injection, is a single-use pre-filled syringe (PFS) containing 1.0 ml of a clear, colorless to slightly yellow, sterile, non-pyrogenic solution. |
Inclusion Criteria: 1. Men or women at least 18 years of age or older 2. Subjects must have a confirmed and documented RRMS diagnosis as defined by the Revised McDonald criteria, with relapse onset disease or a relapsing-remitting disease course 3. Subjects must be ambulatory with a Kurtzke Expande...
GA/mL is a small molecule being developed for the treatment of Relapsing-Remitting Multiple Sclerosis. It is currently in Phase 3 clinical development. The drug is being studied to evaluate its safety and tolerability in patients with this condition.
GA/mL is being developed by Teva Pharmaceutical Industries Limited, a company traded on the stock exchange under the ticker TEVA. Teva is conducting clinical research on this drug for the treatment of Relapsing-Remitting Multiple Sclerosis.
GA/mL is in Phase 3 clinical development. It is an investigational drug, meaning it has not yet been approved for commercial use. The drug is being studied for its safety and tolerability in patients with Relapsing-Remitting Multiple Sclerosis.
GA/mL has one completed Phase 3 clinical trial with the identifier NCT01874145. This trial, titled "Safety and Tolerability of Glatiramer Acetate," enrolled 209 participants with Relapsing-Remitting Multiple Sclerosis in the United States. The study was active-controlled and included adults aged 18 years and older.
GA/mL is being studied in a clinical trial titled "Safety and Tolerability of Glatiramer Acetate," which suggests that GA/mL may be related to glatiramer acetate. However, the drug is referred to as GA/mL in the development program by Teva Pharmaceutical Industries.