Teva reports FDA approval for three-times-a-week Copaxone 40 mg/mL.
Teva Pharmaceutical Industries
reported that FDA has approved the company’s supplemental new drug application for three-times-a-week Copaxone 40mg/mL, a new dose of Copaxone. This new formulation will allow for a less frequent dosing regimen administered subcutaneously for patients with relapsing forms of multiple sclerosis (MS). In addition to the newly approved dose, daily Copaxone 20 mg/mL will continue to be available.
The FDA approval is based on data from the Phase III Glatiramer Acetate Low-Frequency Administration study of more than 1400 patients, which showed that a 40 mg/mL dose of Copaxone administered subcutaneously three-times-a-week significantly reduced relapse rates at 12 months and demonstrated a favorable safety and tolerability profile in patients with relapsing-remitting MS.
