News Copaxone Use During Pregnancy by RMS Patients Now Possible in EU Copaxone Use During Pregnancy by RMS Patients Now Possible in EU by Patricia Silva, PhD | December 7, 2016 Share this article: Share article via email Copy article link European users ofĀ Copaxone (glatiramer acetate injection, Teva Pharmaceutical) to treatĀ relapsing forms of multiple sclerosis (RMS) will no longer see a warning that the drug should not be used during pregnancy. A report assessing this change in the drug’sĀ marketing authorization within the European Union ā a process known as a āvariations procedureā ā allows forĀ its use during pregnancy by removing a previous “contraindication” to such use. The report was issued by the Medicines and Healthcare Products Regulatory AgencyĀ in the U.K.,Ā with all concerned EU member states agreeing to the change. Approvals by national EU governments of this change will now follow. The report examined collective evidence from women using the drug while pregnant. Researchers also analyzed data from Tevaās Glatiramer Acetate Pharmacovigilance Database, collecting information regarding the treatment’s side effects.Ā The database includesĀ information on more than 8,000 pregnancies collected over more than 20 years. The new EU label will read: āStudies 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.ā In the U.S., Copaxone is classified under theĀ āPregnancy Category Bā label issued byĀ the U.S. Food and Drug Administration (FDA). This label states that animal studies have failed to show that treatment poses a risk to aĀ fetus, butĀ adequate and well-controlled studies in pregnant women are not available. āThis positive outcome is very encouraging,ā Rob Koremans, MD, president and CEO at Teva Global Specialty Medicines, said in a press release. āWhile MS treatments are not recommended during pregnancy, sometimes the benefit of treating a pregnant patient with severe RMS symptoms outweighs the risks. āThe 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,ā Koremans added. āAs a company committed to people with MS, weāre 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 childbearing age,ā saidĀ Gianfranco Nazzi, senior vice president of Specialty Medicines Europe at Teva. Print This Page About the Author Patricia Silva, PhD PatrĆcia holds a PhD in medical microbiology and infectious diseases from the Leiden University Medical Center, Netherlands, and completed a postdoctoral research fellowship at the Instituto de Medicina Molecular, Lisbon, Portugal. Her work in academia was mainly focused on molecular biology and the genetic traits of infectious agents such as viruses and parasites. PatrĆcia earned several travel awards to present her work at international scientific meetings. She is a published author of several peer-reviewed science articles. Tags Copaxone, European Union, glatiramer acetate injection, pregnancy, risk, RMS, Teva Pharmaceutical
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