EU Panel Recommends AstraZeneca's Fasenra for Eosinophilic Granulomatosis with Polyangiitis

AstraZeneca’s Fasenra (benralizumab) has received a positive recommendation from the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) as an add-on treatment for adults with relapsing or refractory eosinophilic granulomatosis with polyangiitis (EGPA). EGPA, a rare immune-mediated vasculitis, can lead to multi-organ damage and can be fatal if untreated.

This recommendation follows the successful MANDARA Phase III trial, the first head-to-head comparison of biologics in EGPA. Results, published in The New England Journal of Medicine, showed nearly 60% of Fasenra-treated patients achieved remission, comparable to those treated with mepolizumab. Notably, 41% of Fasenra patients were able to completely taper off oral corticosteroids, compared to 26% of those on mepolizumab.

Fasenra, already a leading treatment for severe eosinophilic asthma, now holds promise as a transformative option for EGPA. If approved, it would become the second biologic available for this rare disease, potentially offering patients significant relief and a reduction in long-term steroid use.