Tysabri Strength Of Effect Led To Accelerated Approval, FDA Review Shows
This article was originally published in The Pink Sheet Daily
Executive Summary
Review documents characterize Biogen Idec/Elan’s biologic as an “important advance” in multiple sclerosis, but note the accelerated pathway has not previously been used for MS therapy. FDA concludes Tysabri (natalizumab) is “an important advance” beyond other MS treatments, meriting approval on one-year data. Final two-year results support efficacy, but Tysabri’s return to market hinges on resolving safety issues.