Biogen have announced a Two-Part Tofersen Access Program. Beginning in mid-July 2021, after patients in this study currently on placebo transition to active therapy, and before the safety and efficacy of tofersen are established, compassionate use access will be allowed for a subset of the SOD1-ALS population with the most rapidly progressive disease. In the fall of 2021, if results from the Phase 3 study indicate that tofersen is safe and effective, and if no further studies are required, we will initiate an early access program (EAP) for the broad SOD1-ALS population. Full details available here
