Biogen's Qalsody Receives Positive Opinion From CHMP

(RTTNews) - Friday, Biogen Inc. (BIIB) announced that the Committee for Medicinal Products for Human Use or CHMP of the European Medicines Agency has adopted a positive opinion and recommended granting marketing authorization under exceptional circumstances for Qalsody, also known as Tofersen.

This medication aims to treat adults with amyotrophic lateral sclerosis or ALS associated with a mutation in the superoxide dismutase 1 gene.

Biogen indicated that the CHMP's endorsement of Qalsody is backed by data from the 28-week Phase 3 VALOR study, which demonstrated a 60 percent reduction in plasma neurofilament light chain levels in Qalsody recipients compared to those in the placebo group.

If approved by the European Commission, Qalsody will be the first authorized treatment in the European Union specifically targeting a genetic cause of ALS, also known as motor neuron disease.

Biogen also noted that the European Commission will evaluate the CHMP's recommendation for Qalsody, with a decision on marketing authorization in the European Union expected in the second quarter of 2024.