Biogen: positive opinion from the CHMP in Charcot disease

(CercleFinance.com) - 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 authorisation decision, with a final decision expected in Q2 2024.


Copyright (c) 2024 CercleFinance.com. All rights reserved.