EU approval for Fasenra in eosinophilic granulomatosis with polyangiitis

AstraZeneca’s (LSE: AZN) Fasenra (benralizumab) 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), 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 recommendation from the European Medicines Agency human health committee, CHMP, and was based on positive results from the MANDARA Phase III trial.

The UK pharma major noted that MANDARA was the first head-to-head non-inferiority trial of biologics in patients with EGPA. Patients were randomized to receive either a single 30mg subcutaneous injection of Fasenra, or three separate 100mg subcutaneous injections of mepolizumab every four weeks.