AstraZeneca’s Fasenra (benralizumab) has been approved in the European Union (EU) as an add-on treatment for adult patients with relapsing or refractory eosinophilic granulomatosis with polyangiitis (EGPA).

EGPA is a rare, immune-mediated vasculitis that can result in damage to multiple organs, and without treatment, can be fatal.

The approval by the European Commission follows the positive opinion of the Committee for Medicinal Products for Human Use (CHMP).

The decision was based on positive results from the MANDARA Phase III trial, in which nearly 60% of Fasenra-treated patients achieved remission, which was comparable to mepolizumab-treated patients.

Data also showed 41% of Fasenra-treated patients fully tapered off oral corticosteroids (OCS) versus 26% in the comparator arm.

Bernhard Hellmich, Chair of the Department of Internal Medicine, Rheumatology, and Immunology at the Medius Klinik Kirchheim, Teaching Hospital of the University of Tübingen in Germany, Co-Director of the Vasculitis Center Tübingen-Kirchhei, and MANDARA Principal Investigator said: “People living with EGPA suffer debilitating symptoms, organ damage and even death. By directly targeting and removing eosinophilic inflammation with benralizumab, I hope that we will see more patients achieve remission as well as a reduction in the reliance on oral corticosteroids, which can cause serious and long-term side effects.”

Approximately half of patients with EGPA have adult-onset severe eosinophilic asthma (SEA). Fasenra is currently approved as an add-on maintenance treatment for SEA in more than 80 countries. It was approved for EGPA in the US in September.

Ruud Dobber, Executive Vice President, BioPharmaceuticals Business Unit, AstraZeneca, said: “Today’s approval of Fasenra, with its convenient, single-monthly injection is a positive step forward for patients with EGPA. Fasenra has been a well-established treatment for many years in thousands of people with severe eosinophilic asthma and we are pleased to now offer a much-needed treatment option for those living with EGPA in Europe.”

Diana Spencer, Senior Digital Content Editor, DDW