Teva Pharmaceutical Industries Ltd have announced that the label for COPAXONE® (glatiramer acetate) injection 20mg/mL, used for treatment in patients with relapsing forms of multiple sclerosis (RMS), has been updated in the UK to remove the pregnancy contraindication.
The label update followed an extensive analysis by regulatory authorities of available pregnancy cases among women who were already taking COPAXONE® when they learned they were pregnant. A supporting analysis was also provided comparing data from Teva’s Glatiramer Acetate (GA) Pharmacovigilance Database which captured more than 8,000 pregnancies over a period of more than 20 years.
Staying on an MS treatment like COPAXONE® 20 mg/mL is now an option women can discuss with their doctor because COPAXONE® is no longer contraindicated during pregnancy.
As a precautionary measure, it is preferable to avoid the use of COPAXONE® during pregnancy unless the benefit to the mother outweighs the risk to the foetus.
Professor Gavin Giovannoni, Chair of Neurology – Blizard Institute, Barts and The London, said, “People with multiple sclerosis want to live normal lives, but, for many women with relapsing MS, having to decide between planning a family and staying on their treatment to manage relapses is a reality they have to face. This label update provides specialists and their patients with MS, who are considering starting or extending their family, an important option in relation to their treatment of MS during pregnancy.”
For more information, visit www.tevapharm.com
Published online: 14/3/17