Biopharmaceutical company AstraZeneca plc (STO:AZN) (LON:AZN) (Nasdaq:AZN) announced on Monday that Fasenra (benralizumab) has been recommended for approval in the European Union for the treatment of eosinophilic granulomatosis with polyangiitis (EGPA).
EGPA is a rare autoimmune disease that can result in damage to multiple organs and, without treatment, can be fatal.
The European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) based its positive opinion on results from a Phase III trial which showed nearly 60% of Fasenra-treated patients achieved remission. This was comparable to mepolizumab, the only approved EGPA treatment. Data also showed that 41% of Fasenra-treated patients fully stopped taking oral corticosteroids (vs. 26% in the comparator arm).
Fasenra was recently approved in the United States for the treatment of EGPA. It is also approved for severe eosinophilic asthma in over 80 countries.
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