Biogen's Qalsody 'sets a precedent for personalized treatment in ALS'

Last week, the US Food and Drug Administration (FDA) approved Qalsody (tofersen) to treat amyotrophic lateral sclerosis (ALS) associated with a mutation in the superoxide dismutase 1 (SOD1) gene (SOD1-ALS).

Developed by US biotech Biogen (Nasdaq: BIIB), Qalsody is an antisense oligonucleotide that targets SOD1 mRNA to reduce the synthesis of SOD1 protein.

This indication is granted under accelerated approval based on reduction in plasma neurofilament light chain observed in patients treated with Qalsody.