The active ingredient in GA Depot, known fully as glatiramer acetate, is already approved for the treatment of multiple sclerosis. Glatiramer acetate is thought to modulate the immune system to reduce the inflammatory attack that drives MS. This experimental therapy, now in clinical trials, is designed to be administered once per month via injection into muscle. A slow-release formulation, it would allow less frequent dosing than the currently approved therapies, marketed as Copaxone and generics, which are given once daily or several times per week as an under-the-skin (subcutaneous) treatment.
Mapi, the company developing GA Depot, is running a Phase 3 clinical trial that is testing the therapy in people with relapsing forms of multiple sclerosis. Pending positive results, the trial is expected to support an application to the U.S. Food and Drug Administration (FDA) requesting the treatment’s approval. However, it is too early to say if or when GA Depot might be approved.
Clinical trials testing GA Depot have not enrolled participants who were pregnant or breastfeeding. It is therefore unknown whether the experimental medication is safe for use in these situations. Other formulations of glatiramer acetate also have not been rigorously studied in pregnant people.
In an early clinical trial that enrolled patients who had been on stable Copaxone treatment for their multiple sclerosis, most who switched to GA Depot showed no signs of disease activity — including no relapses, disability worsening, or new MRI lesions — after one year of treatment.
Hair loss and weight gain have not been reported as side effects of GA Depot in clinical trials. Studies testing other formulations of glatiramer acetate also have not reported these side effects. Patients who experience unexpected reactions after starting a new medication are advised to consult their healthcare team.
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