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Babies of women with relapsing multiple sclerosis (RMS) who receive daily injections of Copaxone (glatiramer acetate) while pregnant carry the same risk of developing birth defects as babies as a whole, according to a study by the therapy’s developer, Teva Pharmaceutical Industries.
The findings can help doctors counsel and treat women with RMS who become pregnant. The study, “Pregnancy Outcomes From The Branded Glatiramer Acetate Pregnancy Database,” was published in the International Journal of MS Care.
Copaxone is a synthetic protein that simulates the production of myelin, a substance that protects nerve fibers in the brain and spinal cord and that is degraded in MS. The drug also suppresses the immune system by preventing T-cells — a type of immune system cells — from damaging myelin in a process called demyelination.
There have been no well-controlled studies in pregnant women’s use of Copaxone until now.
Teva decided to investigate whether babies born to MS patients treated with Copaxone while pregnant were at higher risk of having a congenital problem than babies as a whole.
Researchers compared data on babies born to Copaxone-treated MS patients with data on babies born to healthy women.
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