The Food and Drug Administration has approved a new higher-dose subcutaneous injection formulation of glatiramer acetate that is injected three times per week instead of daily, according to the manufacturer, Teva.
The approval, announced Jan. 28, is based on the randomized, blinded, placebo-controlled GALA (Glatiramer Acetate Low Frequency Administration) study, in which 943 relapsing-remitting multiple sclerosis patients were randomized to 40 mg of subcutaneous glatiramer acetate (Copaxone) three times weekly and 461 patients to matched placebo injections. (Read about the trial’s results in a report out of the 2013 American Academy of Neurology annual meeting).
Teva said that it is shipping the 40-mg dose to distribution outlets immediately and it should be available to patients "within days." The new label information can be found here.
The daily 20-mg/mL subcutaneous injection formulation, approved in 1996, will continue to be available.