(CercleFinance.com) – Biogen announces 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’s disease .
This application concerns the treatment of adults suffering from amyotrophic lateral sclerosis (ALS) associated with a mutation in the superoxide dismutase 1 gene, which would make Qalsody the first treatment targeting a genetic cause of ALS authorized in the EU.
The CHMP recommendation will now be considered by the European Commission for a decision on marketing authorization in the European Union, with the final decision expected in the second quarter of 2024.
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