European users of Copaxone (glatiramer acetate injection, Teva Pharmaceutical) to treat 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’s marketing authorization within the European Union — a process known as a “variations procedure” — allows for its use during pregnancy by removing a previous “contraindication” to such use. The report was issued by the Medicines and Healthcare Products Regulatory Agency in the U.K., 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 Teva’s Glatiramer Acetate Pharmacovigilance Database, collecting information regarding the treatment’s side effects. The database includes information on more than 8,000 pregnancies collected over more than 20 years.
The new EU label will read:
“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.”
In the U.S., Copaxone is classified under the “Pregnancy Category B” label issued by the U.S. Food and Drug Administration (FDA). This label states that animal studies have failed to show that treatment poses a risk to a fetus, but adequate and well-controlled studies in pregnant women are not available.
“This positive outcome is very encouraging,” Rob Koremans, MD, president and CEO at Teva Global Specialty Medicines, said in a press release. “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,” Koremans added.
“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 childbearing age,” said Gianfranco Nazzi, senior vice president of Specialty Medicines Europe at Teva.