March 4, 2009, Updated September 24, 2012

FDA approves Teva’s Copaxone for first episode of multiple sclerosisThe US Food and Drug Administration (FDA) has approved an expanded indication for the drug Copaxone, developed by Israel’s Teva Pharmaceutical Industries, to include the treatment of patients who have experienced a first clinical episode and have magnetic resonance imaging (MRI) features consistent with multiple sclerosis (MS).
The FDA’s approval was granted after a long-term study, and follows a similar decision by the Medicines and Healthcare Products Regulatory Agency (MHRA) in February under which 24 European Union states recognized an expanded label for Copaxone to include the treatment of patients with clinically isolated syndrome (CIS) suggestive of MS.
Up to 85 percent of MS patients initially experience a single neurological event suggestive of MS, known as CIS, and it has been demonstrated that early treatment initiation delays conversion from CIS to clinically definite MS (CDMS). This expanded indication in the US and Europe allows patients to begin treatment with Copaxone from the very earliest stage of the disease.

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Jason Harris

Jason Harris

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