Biogen Inc. announced April 25 that the U.S. Food and Drug Administration (FDA) has approved QALSODY™ (Tofersen) 100 mg/15mL Injection for the treatment of amyotrophic lateral sclerosis (ALS) in adults with a mutation in the superoxide dismutase 1 (SOD1) gene. This indication is approved under accelerated approval based on the reduction in plasma neurofilament light chain (NfL) observed in patients treated with QALSODY. Continued approval for this indication may be subject to verification of clinical benefit in one or more confirmatory studies. The ongoing Phase 3 ATLAS study with tofersen in patients with presymptomatic SOD1 ALS will serve as a confirmatory study.
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