AstraZeneca says Fasenra met primary endpoint in MANDARA trial

AstraZeneca reports high-level results from the MANDARA Phase III trial, which showed AstraZeneca’s Fasenra met the primary endpoint of the trial and demonstrated non-inferior rates of remission compared to mepolizumab in patients with eosinophilic granulomatosis with polyangiitis, or EGPA, who were receiving oral corticosteroids with or without stable immunosuppressive therapy. “MANDARA is the first Phase III head-to-head trial of biologics in EGPA and compared the efficacy and safety of Fasenra versus mepolizumab, the only currently approved treatment. In the blinded trial, patients were randomised to receive either a single 30mg subcutaneous injection of Fasenra or three separate 100mg subcutaneous injections of mepolizumab once every four weeks,” the company stated. Full results from MANDARA will be presented at an upcoming medical meeting and data will be shared with health authorities around the world, AstraZeneca noted. Sharon Barr, Executive Vice President, BioPharmaceuticals R&D, AstraZeneca, said: “The positive results from MANDARA demonstrate that Fasenra, which has a unique mechanism of action and directly targets eosinophils, can help patients achieve remission from the debilitating impacts of this inflammatory disease with a more convenient single monthly subcutaneous injection.”