Biogen confirms FDA grants accelerated approval for Qalsody

Biogen (BIIB) announced that the U.S. Food and Drug Administration has approved Qalsody 100 mg/15mL injection for the treatment of amyotrophic lateral sclerosis, or ALS, in adults who have a mutation in the superoxide dismutase 1, or SOD1, gene. "This indication is approved under accelerated approval based on reduction in plasma neurofilament light chain 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," the company stated. Biogen collaborated with Ionis Pharmaceuticals (IONS) on the early development of tofersen. "Qalsody will be made available for shipment in the U.S. to healthcare providers in approximately one week. Biogen anticipates there may be variation in time to treatment as institutions and treatment centers learn about Qalsody," the company added.