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

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

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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Several new drugs for multiple sclerosis could launch within the next two years, but amid escalating drug costs, payors are taking a harder look at the therapeutic category. New drugs will face increasing reimbursement hurdles, as payors implement the first prior authorization and step therapy protocols and look for ways to implement further cost reductions.

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