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 used for the treatment of relapsing-remitting multiple sclerosis, a form of MS marked by episodes of new or worsening neurological symptoms followed by periods of recovery. It is a small molecule therapy being developed by Teva Pharmaceutical Industries Limited for this neurological indication.
GA/mL is developed by Teva Pharmaceutical Industries Limited, which trades under the ticker TEVA. Teva is the sponsor behind the clinical development program for this relapsing-remitting multiple sclerosis therapy.
GA/mL is in Phase 3 clinical development for relapsing-remitting multiple sclerosis. It is an investigational therapy and has not been approved by the FDA. One Phase 3 trial has been completed, and no trials are currently active.
GA/mL has been studied in one completed Phase 3 trial, NCT01874145, titled Safety and Tolerability of Glatiramer Acetate. That trial enrolled 209 participants with relapsing-remitting multiple sclerosis in the United States, accepted participants aged 18 years and older of all sexes, and used an active-controlled design.
Yes, the completed Phase 3 trial of GA/mL, NCT01874145, was randomized and used an active control for comparison. It was not double-blind, and it enrolled 209 participants with relapsing-remitting multiple sclerosis. The study did not select patients based on a biomarker.