Biogen/Ionis’ Tofersen: US FDA Considering Both Accelerated And Regular Approval In ALS
Executive Summary
FDA seeks advisory committee input on whether there is ‘convincing evidence’ to support regular approval for treatment of SOD1-ALS patients even though lone Phase III trial failed its primary endpoint; companies filed for accelerated approval on the basis that a reduction in plasma neurofilament light chain is reasonably likely to predict clinical benefit.
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