Posted by Michael Wonder on 25 Apr 2023
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
25 April 2023 - FDA granted accelerated approval of Qalsody based on a reduction of neurofilament, a marker of neurodegeneration.
Biogen announced today that the US FDA has approved Qalsody (tofersen) 100 mg/15 mL injection for the treatment of amyotrophic lateral sclerosis in adults who have a mutation in the superoxide dismutase 1 gene.
