Teva Gets Positive Outcome For COPAXONE 40 Mg/ml 3 Times Weekly Label In Europe

(RTTNews) - Teva Pharmaceutical Industries Ltd. (TEVA) announced Monday 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.

COPAXONE is indicated for the treatment of patients with relapsing forms of multiple sclerosis or RMS.

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.

The removal of the pregnancy contraindication follows a Positive Variation Assessment Report issued by the United Kingdom's Medicines and Healthcare Products Regulatory Agency, and agreed by all Concerned Member States in Europe, that were involved in the procedure. Granting of national approvals by all involved EU Member States will happen in the near future.

The variation approval was granted based on an analysis of prospective pregnancy cases with known outcome and confirmed exposure to COPAXONE 40 mg/ ml 3 times weekly, from Teva's Glatiramer Acetate 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 cases.

Rob Koremans, President and CEO, Teva Global Specialty Medicines, said, "While it is still preferable not to use any MS treatments during pregnancy, it is now possible for women to consult with their doctor and consider taking COPAXONE during pregnancy if appropriate and depending on their individual circumstances. For those women who can't stop taking the medication, who were previously discouraged from having children, the removal is excellent news and further underlines the established safety, efficacy and tolerability profile of COPAXONE."