Thursday May 18 2017 12:09 PM

• Pregnancy contraindication removed from Copaxone 40mg/ml 3-times weekly, the first drug in this category to be cleared;
• Positive report agreed at European level, approval granted by Irish regulator 
• Approximately 9,000 people in Ireland have multiple sclerosis, an autoimmune disease of the nervous system that disproportionately affects women of childbearing age

Irish doctors can now prescribe a treatment option for women with relapsing forms of multiple sclerosis (MS) who are seeking to start a family. 

Teva Pharmaceuticals Ireland has announced that the pregnancy contraindication for the Glatiramer Acetate injection, Copaxone 40mg/ml 3-times weekly, has been removed from the European label. An equivalent change was approved for Copaxone 20mg/ml in December 2016.

No other drug in this category has had the pregnancy contraindication removed.

MS is an autoimmune disease of the nervous system which damages the insulating covers of nerve cells in the brain and spinal cord, affecting vision, muscle control and other bodily functions. Approximately 9,000 people in Ireland live with the disease, and roughly 250 new cases are diagnosed each year. MS disproportionately affects women of childbearing age (20-40 years old).

The removal of the pregnancy contraindication follows a Positive Variation Assessment Report issued by the UK's Medicines and Healthcare Products Regulatory Agency (MHRA), and agreed by all Concerned Member States (CMS) in Europe that were involved in the procedure. Ireland’s medicines regulator, the Health Products Regulatory Association (HPRA), has also granted approval. 

The approval was granted based on an analysis of prospective pregnancy cases with known outcome and confirmed exposure to Copaxone 20mg/ml, from Teva’s Glatiramer Acetate (GA) Pharmacovigilance Database. This further strengthens the conclusion of the robust analysis of Copaxone 20 mg/ml pregnancy data, based on more than 2,000 pregnancy cases1. To date, this is the largest analysed dataset of pregnant women with MS who were exposed to disease modifying therapies during pregnancy.

Dr Greg Hays, Medical Director, Teva Pharmaceuticals Ireland, said the contraindication removal is significant for women with MS seeking to start a family. 

“MS is a debilitating disease that disproportionately affects young women at an age when they are most likely to be considering starting a family. 

“Teva is committed to helping women with relapsing forms of the disease lead the complete lives they desire. While it is still preferable to avoid using MS treatments during pregnancy, in appropriate situations, the removal of the contraindication from Copaxone is welcome for those who wish to remain on their medication or who were previously advised to stop taking their medication for the duration of the pregnancy.”

Ms. Ava Battles- Chief Executive Officer at the Multiple Sclerosis Society of Ireland-said: “As MS is more prevalent in women of childbearing age than in any other group, the removal of the contraindication from Copaxone allows for Irish doctors to prescribe a treatment option (in appropriate situations) for women with relapsing forms of multiple sclerosis (MS) who are seeking to start a family.”