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FDA Grants Accelerated Approval for QALSODY™ (tofersen) for SOD1-ALS, a Major Scientific Advancement as the First Treatment to Target a Genetic Cause of ALS

2023 04 Biogen News Release FDA Approval Of Qalsody
  • FDA granted accelerated approval of QALSODY based on a reduction of neurofilament, a marker of neurodegeneration
  • Superoxide dismutase 1 (SOD1)-amyotrophic lateral sclerosis (ALS) is a devastating, uniformly fatal, and ultra-rare genetic form of ALS with approximately 330 people in the U.S. living with the disease

CAMBRIDGE, Mass., April 25, 2023 (GLOBE NEWSWIRE) — Biogen Inc. (Nasdaq: BIIB) announced today 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 who have a mutation in the superoxide dismutase 1 (SOD1) gene. This indication is approved under accelerated approval based on reduction in plasma neurofilament light chain (NfL) observed in patients treated with QALSODY. Continued approval for this indication may be contingent upon verification of clinical benefit in confirmatory trial(s). The ongoing Phase 3 ATLAS study of tofersen in people with presymptomatic SOD1-ALS will serve as the confirmatory trial.

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