New Copaxone Dosing Approved for Fewer Injections
On January 28, 2014, Teva Pharmaceutical Industries Ltd. announced that the new, three-times-per-week dosing of Copaxone® (glatiramer acetate), at the more concentrated dose of 40 mg, has been approved by the FDA. This new formulation enables individuals who take Copaxone to reduce their number of subcutaneous injections by 60 percent – from seven times per week to three times – once they are prescribed the new dosing regimen by their doctor. Teva states that in addition to the newly approved dose, daily Copaxone at the traditional 20-mg dose will continue to be available.
The initial FDA-approved dose for Copaxone is 20 mg per day, given subcutaneously. The GALA trial was a randomized, placebo-controlled trial of Copaxone dosed at 40 mg and given by subcutaneous injection three-times weekly versus placebo. Data from this trial were first presented in fall 2012.
This three-times weekly dosing strategy of Copaxone reduced relapse rates by 34 percent compared with placebo, and reduced new MRI lesions by 35 percent. This is comparable with the expected efficacy of Copaxone given at the standard dose of 20 mg injected daily. No new safety concerns were identified with this new dosing regimen.
Teva Pharmaceutical Industries Ltd. announced in May 2013 that the FDA had accepted a supplemental New Drug Application (sNDA) for Copaxone at this higher dose and reduced frequency. Now that this new dosing has been approved by the FDA, individuals with relapsing forms of MS who take Copaxone have a new treatment option requiring fewer weekly injections.
(The study information given above was taken from MSAA’s 2014 MS Research Update, which is still in production at the time of this writing. This fully revised update, written by Stephen Krieger, MD, will be available from MSAA in February 2014.)