The U.S. Food and Drug Administration (FDA) has granted approval to AstraZeneca Plc’s Fasenra (benralizumab) for the treatment of eosinophilic granulomatosis with polyangiitis (EGPA), a rare and complex inflammatory disease. EGPA, also known as Churg-Strauss syndrome, is an immune-mediated vasculitis, meaning it causes inflammation of the blood vessels, potentially leading to damage in various organs.
This approval is based on the robust results of the MANDARA Phase 3 trial, which was published in The New England Journal of Medicine. The MANDARA trial, the first of its kind to directly compare two biologic therapies in EGPA patients, showed that Fasenra achieved remission in nearly 60% of patients, a rate comparable to those treated with GSK Plc’s Nucala (mepolizumab), the currently approved EGPA treatment.
Furthermore, the data revealed that 41% of patients treated with Fasenra were able to completely taper off oral corticosteroids (OCS) compared to just 26% in the mepolizumab group. This ability to reduce corticosteroid dependence is crucial for patients as prolonged use can lead to serious side effects. The safety and tolerability of Fasenra observed in the MANDARA trial aligned with its established safety profile.
It’s important to note that approximately half of EGPA patients experience adult-onset severe eosinophilic asthma, often accompanied by sinus and nasal symptoms. Fasenra’s approval signifies a significant advancement in treatment options for this complex disease. Notably, it becomes the second biologic approved for EGPA, offering patients and their physicians a new and potentially more effective alternative.
Beyond its EGPA approval, Fasenra has already established itself as a valuable treatment option for severe eosinophilic asthma. It is currently approved as an add-on maintenance therapy for this condition in over 80 countries. Additionally, Fasenra is approved for use in children and adolescents aged six and above in the U.S. and Japan.
This latest approval for Fasenra further underscores AstraZeneca’s commitment to developing innovative therapies for rare and challenging diseases. The company’s efforts continue to shape the landscape of treatment options for patients facing debilitating conditions.
