Copaxone gets EU approval to treat syndrome suggestive of MS

Israel’s Teva Pharmaceutical Industries has received expanded approval in the European Union for its blockbuster Copaxone to be used as a treatment to prevent the development of multiple sclerosis.

Specifically the UK’s Medicines and Healthcare products Regulatory Agency has backed the expansion of the label for Copaxone (glatiramer acetate) to include the treatment of patients with clinical isolated syndrome suggestive of MS. The approval covers 24 EU member countries under the mutual recognition procedure.

The green light is based on findings from the PreCISe study, conducted in 481 patients with CIS. It demonstrated that Copaxone significantly reduced the risk of developing clinically-definite MS by 45% versus placebo and prolonged the quartile time to conversion to CDMS to 722 days, versus 336 days in those patients receiving placebo.

Teva noted that Copaxone is the only relapsing-remitting MS treatment with prospective long-term data demonstrating that eight out of 10 patients adhering to therapy are still able to walk unassisted after a mean of 15 years of therapy and 22 years of disease duration. The firm’s vice president for global innovative resources, Moshe Manor, said that Copaxone “provides clear benefits from early phase of the disease to patients presenting with a first clinical event suggestive of MS”.

Approval of an expanded label to include the treatment of CIS patients was also provided by Australia’s Therapeutic Goods Administration, and a similar application is currently under review by the US Food and Drug Administration.