Ionis Pharmaceuticals (IONS) "announced that its partner Biogen (BIIB) has received U.S. Food and Drug Administration approval of QALSODY, or tofersen, 100 mg/15mL injection for the treatment of amyotrophic lateral sclerosis, or ALS, in adults who have a mutation in the superoxide dismutase gene. This indication is approved under accelerated approval based on a 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 from ongoing trial(s). The ongoing Phase 3 ATLAS study of tofersen in people with presymptomatic SOD1-ALS will serve as the confirmatory study. QALSODY is the first and only approved treatment to target a genetic cause of ALS and the latest Ionis-discovered medicine to gain market approval."
Published first on TheFly
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