Biogen has announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has issued a positive opinion concerning the marketing authorization under exceptional circumstances for Qalsody 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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