On May 30, 2024, Biogen announced that the European Commission (EC) had granted marketing authorization under exceptional circumstances and maintained orphan designation for QALSODY® (tofersen) for the treatment of adults with amyotrophic lateral sclerosis (ALS) associated with a mutation in the superoxide dismutase 1 gene (SOD1-ALS).

QALSODY is the first treatment approved in the European Union to target a genetic cause of ALS, also known as motor neuron disease (MND).