3X a week glatiramer acetate (Copaxone); innovation or life-cycle management? #MSBlog #MSResearch
Objective: To assess the efficacy and safety of glatiramer acetate (GA) 40 mg administered three times weekly (tiw) compared with placebo in RRMSers.
Methods: This randomized, double-blind study was conducted in 142 sites in 17 countries. RRMSers with at least one documented relapse in the 12 months before screening, or at least two documented relapses in the 24 months before screening, and an Expanded Disability Status Scale score ≤5.5, were randomized 2:1 to receive either subcutaneous (sc) GA 40 mg tiw (1 mL) or placebo for 12 months.
Results: Of 1524 MSers screened, 1404 were randomized to receive GA 40 mg sc tiw (n=943) or placebo (n=461). Ninety-three percent and 91% of MSers in the placebo and GA groups, respectively, completed the 12-month study. GA 40 mg tiw was associated with a 34.0% reduction in risk of confirmed relapses compared with placebo (mean annualized relapse rate 0.331 vs 0.505; p< 0.0001). MSers who received GA 40 mg tiw experienced highly significant reduction (p< 0.0001) in the cumulative number of gadolinium (Gd)-enhancing T1 (44.8%) and new or newly enlarging T2 lesions (34.7%), at months 6 and 12. GA 40 mg tiw was safe and well tolerated. The most common adverse events in the GA group were injection-site reactions (35.5% with GA vs 5.0% with placebo).
Interpretation: GA 40 mg sc tiw is a safe and effective regimen for the treatment of RRMS, providing the convenience of fewer sc injections per week.
“Two days ago it was a new interferon preparation that could be given every 2 weeks or possibly every 4 weeks and now its double-dose glatiramer acetate (Copaxone) that can be give 3X times a week instead of every day. Is this innovation or life-cycle management of blockbuster drugs that are beginning to get ready for the invasion of cheaper biosimilars?”
Other posts of interest:
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