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Fasenra Phase III EGPA trial met primary endpoint
Fasenra Phase III EGPA trial met primary endpoint.
About this update from Astrazeneca Plc
[{"type":"text","content":"\n\n11 September 2023\n \nFasenra met the primary endpoint in the MANDARA Phase III trial in eosinophilic granulomatosis with polyangiitis (EGPA)\n \nFirst head-to-head trial of biologics in EGPA, comparing a single monthly injection of Fasenra to three injections per month of mepolizumab\n \nPositive high-level results from the MANDARA Phase III trial showed AstraZeneca's Fasenra (benralizumab) met the primary endpoint of the trial and demonstrated non-inferior rates of remission compared to mepolizumab in patients with eosinophilic granulomatosis with polyangiitis (EGPA) who were receiving oral corticosteroids (OCS) with or without stable immunosuppressive therapy.\n \nMANDARA 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.1,2 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.1,2\n \nEGPA is a rare, immune-mediated vasculitis that is caused by inflammation of small to medium-sized blood vessels.3,4 Approximately half of patients with EGPA have concomitant adult-onset severe eosinophilic asthma (SEA).5 EGPA can result in damage to multiple organs, including lungs, skin, heart, gastrointestinal tract and nerves, which accumulates over time and without treatment can be fatal.3,6\n \nDr Michael Wechsler, Principal Investigator said: \"The positive MANDARA trial results are exciting because patients with eosinophilic granulomatosis with polyangiitis today have limited treatment options but face crippling symptoms, which can even be fatal if not treated. This trial demonstrates that a biologic medicine given in a single monthly injection could help patients achieve remission rates comparable to the current standard of care, adding to the importance of benralizumab as a potential treatment option for eosinophilic granulomatosis with polyangiitis.\"\n \nSharon 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 ...