Biogen: positive opinion from the CHMP in Charcot disease
This application concerns the treatment of adults with amyotrophic lateral sclerosis (ALS) associated with a mutation in the superoxide dismutase 1 gene, making Qalsody the first treatment targeting a genetic cause of ALS to be authorized in the EU.
The CHMP's recommendation will now be examined by the European Commission with a view to an EU marketing authorization decision, with a final decision expected in the second quarter of 2024.
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