In a groundbreaking development, AstraZeneca (NASDAQ:AZN)'s Fasenra (benralizumab) demonstrated non-inferior rates of remission compared to mepolizumab in the treatment of eosinophilic granulomatosis with polyangiitis (EGPA) patients. The results emerged from the MANDARA Phase III trial, which was the first head-to-head trial of biologics in EGPA.
The trial compared a single 30mg subcutaneous injection of Fasenra administered monthly to three separate 100mg subcutaneous injections of mepolizumab given once every four weeks. The primary endpoint of the trial was met, with Fasenra showing similar rates of remission to mepolizumab in EGPA patients receiving oral corticosteroids (OCS) with or without stable immunosuppressive therapy.
EGPA is a rare, immune-mediated vasculitis caused by inflammation of small to medium-sized blood vessels. It can result in damage to multiple organs, including lungs, skin, heart, gastrointestinal tract and nerves, which accumulates over time and can be fatal without treatment. Approximately half of patients with EGPA also have adult-onset severe eosinophilic asthma (SEA).
Dr Michael Wechsler, Principal Investigator for the MANDARA trial, expressed excitement over the results. He emphasized the significance of these findings given that current treatment options for EGPA are limited and often come with debilitating symptoms. He said that a biologic medicine given in a single monthly injection could help patients achieve remission rates comparable to the current standard of care.
Sharon Barr, Executive Vice President, BioPharmaceuticals R&D, AstraZeneca echoed Dr Wechsler's sentiment. She highlighted that Fasenra, with its unique mechanism of action that directly targets eosinophils, could help patients achieve remission from the debilitating impacts of this inflammatory disease with a more convenient single monthly subcutaneous injection.
Fasenra is a monoclonal antibody that binds directly to IL-5 receptor alpha on eosinophils. It attracts natural killer cells to induce rapid and near-complete depletion of blood and tissue eosinophils in most patients via apoptosis (programmed cell death). The safety and tolerability profile for Fasenra in the trial was consistent with the
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