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Biogen Idec To Pursue Disability Label Claim For BG-12 Despite Missed Endpoint

 
• By Emily Hayes

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.

Biogen Inc. plans to seek labeling for its multiple sclerosis candidate BG-12 that reflects a benefit for reducing disability progression, even though the oral agent missed this endpoint in its second Phase III trial, CONFIRM.

The company plans to submit BG-12 (dimethyl fumarate) in the first half of 2012 and believes it could find a...

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