AMSTERDAM–(BUSINESS WIRE)–Teva Pharmaceutical Industries Ltd. today announced that it has received a positive outcome through the variation procedure to remove the pregnancy contraindication from the European label for (glatiramer acetate injection) COPAXONE® 40 mg/ml 3 times weekly. The product was originally authorized through a decentralized procedure in Europe. An equivalent change has already been approved for COPAXONE® 20 mg/ml in December 2016.
According to the European Multiple Sclerosis Platform (EMSP) around 700,000 people in Europe are affected by Multiple Sclerosis (MS), with a 2:1 ratio between women and men. MS is more common among women of childbearing age compared with any other age group with the average age of diagnosis approximately 30 years, with ~43% of the women starting a family after diagnosis.
The removal of the pregnancy contraindication follows a Positive Variation Assessment Report issued by the United Kingdom’s Medicines and Healthcare Products Regulatory Agency (MHRA; Reference Member State), and agreed by all Concerned Member States (CMS) in Europe, that were involved in the procedure. Granting of national approvals by all involved EU Member States will happen in the near future. COPAXONE® is indicated for the treatment of patients with relapsing forms of multiple sclerosis (RMS).
