AstraZeneca says Fasenra recommended for approval in EU by CHMP

AstraZeneca’s Fasenra has been recommended for approval in the European Union as an add-on treatment for adult patients with relapsing or refractory eosinophilic granulomatosis with polyangiitis. EGPA is a rare, immune-mediated vasculitis that can result in damage to multiple organs, and without treatment, can be fatal. The Committee for Medicinal Products for Human Use of the European Medicines Agency based its positive opinion on results from the MANDARA Phase III trial published in The New England Journal of Medicine,3 which compared the efficacy and safety of Fasenra to the only approved EGPA treatment, mepolizumab, in patients with relapsing or refractory EGPA.3-5 MANDARA was the first head-to-head non-inferiority trial of biologics in patients with EGPA. Patients were randomised to receive either a single 30 mg subcutaneous injection of Fasenra, or three separate 100 mg subcutaneous injections of mepolizumab every four weeks. In the trial, nearly 60% of Fasenra-treated patients achieved remission which was comparable to mepolizumab-treated patients. Data also showed 41% of Fasenra-treated patients fully tapered off oral corticosteroids. The safety and tolerability profile for Fasenra in the MANDARA trial was consistent with the known profile of the medicine.