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.
You may also be interested in...
Tysabri Withdrawal Prompts Biogen Idec To Suspend Financial Guidance
Company plans to issue revised guidance in May after warning investors not to rely on previous financial forecasts. Announcement coincides with news that a third diagnosis of PML was discovered in a clinical trial for Tysabri.
Tysabri Could Return In Fall; Marketing Suspended By Biogen Idec And Elan
One fatal, confirmed case of progressive multifocal leukoencephalopathy and one suspected case prompt withdrawal of multiple sclerosis product; risk/benefit ratio needs to be reestablished, companies say. Return to market would not be unprecedented, but Tysabri’s withdrawal sharpens focus on FDA's drug safety oversight.
Spectrum’s Iso-Vorin Could Clear FDA For Osteosarcoma By First Quarter
The Irvine, Calif., firm also plans sNDAs for a colorectal cancer claim and an oral formulation of the leucovorin relative.