Agios announces EC’s positive decision for sickle cell disease therapy designation
This follows orphan drug status granted by the US Food and Drug Administration (FDA) in November 2020. Currently, mitapivat is approved in the US under the brand name
The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion recommending the approval of Sanofi and Regeneron’s Dupixent (dupilumab) in the European Union (EU) for paediatric patients with chronic spontaneous urticaria (CSU).