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Third Trial For Teva’s Laquinimod Hinges On SPA From FDA

 
• By Jessica Merrill

Teva will initiate a third clinical trial testing the oral multiple sclerosis drug laquinimod after finalizing a special protocol assessment with FDA.

Teva Pharmaceuticals Industries Ltd. will initiate a third Phase III study for the oral multiple sclerosis candidate laquinimod within the “next two to three months,” Head of R&D Global Branded Products Lesley Russell said during a presentation at the Citi 2012 Global Healthcare Conference Feb. 27. The company is waiting to finalize a Special Protocol Assessment with FDA before initiating the study because it is hoping to use a different primary endpoint than the one used in the failed Phase III BRAVO study.

The future of the oral MS treatment has been in question since the drug under-performed on efficacy in the Phase...

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