AstraZeneca’s Fasenra approved in EU for EGPA

AstraZeneca’s (AZN) Fasenra has been approved in the European Union, EU, as an add-on treatment for adult patients with relapsing or refractory eosinophilic granulomatosis with polyangiitis, EGPA. EGPA is a rare, immune-mediated vasculitis that can result in damage to multiple organs, and without treatment, can be fatal. The approval by the European Commission follows the positive opinion of the Committee for Medicinal Products for Human Use and was based on positive results from the MANDARA Phase III trial, published in The New England Journal of Medicine. In the trial, nearly 60% of Fasenra-treated patients achieved remission, which was comparable to mepolizumab-treated patients.3 Data also showed 41% of Fasenra-treated patients fully tapered off oral corticosteroids.