Biogen receives European Commission approval for Qalsody (tofersen), the first therapy to treat a rare, genetic form of ALS

Biogen

30 May 2024 - Qalsody is Biogen’s third rare disease therapy to be approved in the EU, demonstrating the company’s commitment to addressing diseases with a high unmet need.

Biogen announced the European Commission has granted marketing authorisation under exceptional circumstances and maintained orphan designation for Qalsody (tofersen) for the treatment of adults with amyotrophic lateral sclerosis associated with a mutation in the superoxide dismutase 1 gene.

Read Biogen press release

Michael Wonder

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Michael Wonder

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Outcome , Europe , Gene therapy