Biogen Idec To Pursue Disability Label Claim For BG-12 Despite Missed Endpoint
This article was originally published in The Pink Sheet Daily
Relapse reduction in multiple sclerosis was robust, though lower than in the first Phase III trial, but the drug missed the statistical mark on disability progression.
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Teva will initiate a third clinical trial testing the oral multiple sclerosis drug laquinimod after finalizing a special protocol assessment with FDA.
IQWiG’s failure to find any added benefit from Novartis’ oral MS drug Gilenya in two out of three of its target patient groups, on the grounds of insufficient evidence, puts pressure on the drug following a similarly negative recommendation by U.K. cost-watchdog NICE at the end of 2011.
Biogen's drug is poised to become top dog among many oral MS drugs, including Novartis' approved Gilenya, analysts say.