Biogen (BIIB) Reports Topline Phase 3 Results of Tofersen and its Open-Label Extension in SOD1-ALS

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Biogen Announces Topline Results from the Tofersen Phase 3 Study and its Open-Label Extension in SOD1-ALS

October 17, 2021 4:20 PM EDT

In the Phase 3 VALOR study, the primary endpoint as measured by the Revised Amyotrophic Lateral Sclerosis Functional Rating Scale (ALSFRS-R) did not reach statistical significance; however, signs of reduced disease progression across multiple secondary and exploratory endpoints were observedThe totality of evidence from VALOR and its ongoing open-label extension showed that participants who started tofersen earlier experienced better outcomes, further suggesting a positive clinical effectTopline data being presented today at the American Neurological Association 2021 Annual MeetingGiven the high unmet medical need, Biogen will expand its ongoing early access program (EAP) to the broader... More