Teva gets expanded US indication for Copaxone

Israel's Teva Pharmaceutical Industries has received a US Food and Drug  Administration expanded indication for its Copaxone (glatiramer acetate)  to include the treatment of patients who have experienced a first  clinical episode and have magnetic resonance imaging features consistent  with multiple sclerosis.

The FDA granted approval after reviewing the results of the PreCISe  study, which indicated time to development of a second exacerbation was  significantly delayed in patients treated with Copaxone compared to  placebo. The cumulative probability of developing the second attack  during the three-year study period was significantly lower in the  Copaxone group versus the placebo arm (24.7% vs 42.9%).

"Copaxone, the world's leading MS disease-modifying therapy, has  demonstrated the ability to provide treatment benefits very early on,  when patients present with a first clinical episode and have MRI  features consistent with MS," said Moshe Manor, vice president of global  branded products. "This milestone, along with the existing long-term  safety and efficacy data, further position Copaxone as a cornerstone in  MS treatment," he added.