Biogen’s QALSODY® (tofersen), the First Therapy to Treat Rare, Genetic Form of ALS, Received Positive Opinion from CHMP

February 23, 2024

https://www.globenewswire.com/news-release/2024/02/23/2834389/0/en/Biogen-s-QALSODY-tofersen-the-First-Therapy-to-Treat-Rare-Genetic-Form-of-ALS-Received-Positive-Opinion-from-CHMP.html

CAMBRIDGE, Mass., Feb. 23, 2024 (GLOBE NEWSWIRE) — Biogen Inc. (Nasdaq:BIIB) announced the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion recommending a marketing authorization under exceptional circumstances for QALSODY® (tofersen) for the treatment of adults with amyotrophic lateral sclerosis (ALS), associated with a mutation in the superoxide dismutase 1 (SOD1) gene. If authorized by the European Commission (EC), QALSODY will be the first treatment approved in the European Union to target a genetic cause of ALS, also known as motor neuron disease (MND).

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