The FINANCIAL — Teva Pharmaceutical Industries Ltd. on December 6 announced that it has received a positive outcome through the variation procedure to remove the pregnancy contraindication from the European label for COPAXONE (glatiramer acetate injection) 20 mg/mL.
The product was originally authorized through a decentralized procedure in Europe.
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), according to Teva.
The removal of the contraindication is based on a comprehensive examination of available prospective pregnancy cases with known outcome and confirmed exposure to COPAXONE. 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.
The label now reads:
“Studies in animals have not shown reproductive toxicity. Current data on pregnant women indicate no malformative or feto/ neonatal toxicity of COPAXONE. To date, no relevant epidemiological data are available. 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 fetus.”
“This positive outcome is very encouraging,” said Rob Koremans, M.D., President & CEO, Teva Global Specialty Medicines. “While MS treatments are not recommended during pregnancy, sometimes the benefit of treating a pregnant patient with severe RMS symptoms outweighs the risks. The update to the product information will provide physicians with helpful information as they make individual treatment decisions with their pregnant patients or patients who are trying to conceive with RMS.”
“As a company committed to people with MS, we’re pleased to have presented this important data to the regulators and we believe that it further underscores the established safety, efficacy and tolerability profile of COPAXONE, providing new options for physicians and women of child bearing age” said Gianfranco Nazzi, Senior Vice President, Specialty Medicines Europe, at Teva.