WESTON (dpa-AFX) - 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.



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