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Biogen Announces U.S. Approval for QALSODY™ (tofersen) for SOD1-ALS

Wednesday, April 26, 2023

Biogen 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.

QALSODY is the first approved treatment to target a genetic cause of amyotrophic lateral sclerosis (ALS). Positive effects of QALSODY were resulted in slowing the progression of ALS in people with SOD1 mutations. The FDA’s approval of QALSODY gives hope to people living with this rare form of ALS to experience a reduction in decline in strength, clinical function, and respiratory function.

QALSODYTM (tofersen) is a prescription medicine used to treat 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).

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