Benralizumab, approved by the EU for the treatment of eosinophilic granulomatosis with polyangiitis

Benralizumab, a drug developed by Astrazeneca, has obtained approval from the European Commission as an additional treatment for adult patients suffering from relapsed or refractory eosinophilic granulomatosis with polyangiitis (EGPA). EGPA is a rare immune-mediated vasculitis that can cause damage to several organs and, if not adequately treated, can be fatal for the patient. As explained by AstraZeneca «the European Commission’s approval follows the recommendations of the Committee for Medicinal Products for Human Use and is based on the positive results of the Phase III Mandara study, published in The New England Journal of Medicine. Mandara is the first comparative non-inferiority study between biological drugs in patients with EGPA. Patients were randomized to receive a single subcutaneous injection of benralizumab 30mg, or three subcutaneous injections of mepolizumab 100mg every four weeks.”

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Turning point in the therapeutic management of patients

Raffaela Fede, medical director of Astrazeneca Italia, observed that «the European approval of benralizumab for the treatment of adult patients with EGPA defines a turning point in the therapeutic management of patients affected by it. The results of the Mandara study mark a fundamental step for the treatment of this rare and complex pathology, opening the doors to new treatment perspectives to offer tangible hope to patients and significantly improve their quality of life.”

Therapeutic solutions in areas of unmet clinical need

For Fede this is «an important result, which reaffirms our constant commitment to research thanks to the implementation of development programs for molecules such as benralizumab, with the aim of bringing therapeutic solutions to areas, such as that of rare pathologies, characterized by an important clinical need not yet satisfied. We are therefore proud to make benralizumab available to patients and the scientific community, offering innovative and personalized solutions to address the unique challenges of this disease.”