Fasenra Gets EU Approval For Treating Eosinophilic Granulomatosis With Polyangiitis

AstraZeneca’s Fasenra (benralizumab) has received approval from the European Union (EU) as an additional treatment for adults suffering from relapsing or refractory eosinophilic granulomatosis with polyangiitis (EGPA). This rare immune-mediated vasculitis can severely affect various organs and may lead to fatal outcomes if left untreated.

The European Commission's decision came after a positive recommendation from the Committee for Medicinal Products for Human Use and was supported by promising findings from the MANDARA Phase III trial, which was published in The New England Journal of Medicine. This trial marked the first head-to-head comparison of biologics in patients with EGPA. Participants were randomly assigned to receive either a single subcutaneous injection of 30 mg of Fasenra or three doses of 100 mg of mepolizumab administered every four weeks.

Results from the trial indicated that nearly 60% of patients treated with Fasenra achieved remission, similar to those receiving mepolizumab. Additionally, 41% of patients on Fasenra successfully tapered off oral corticosteroids, compared to 26% in the mepolizumab group, showing a significant difference in favour of Fasenra.

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, commented “People living with EGPA suffer debilitating symptoms, organ damage and even death.”

He further said that, “Today’s approval provides an important treatment option for people living with EGPA in the EU. 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.”   

Ruud Dobber, Executive Vice President, BioPharmaceuticals Business Unit, AstraZeneca, said in a statement, “We remain committed to helping patients with some of the hardest-to-treat diseases. 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.”   

The MANDARA trial demonstrated that Fasenra's safety and tolerability align with its established profile. Notably, around 50% of patients diagnosed with eosinophilic granulomatosis with polyangiitis (EGPA) also suffer from adult-onset severe eosinophilic asthma (SEA), which frequently presents with sinus and nasal symptoms. 

Fasenra is only the second biologic to receive approval for treating this condition. Currently, it is sanctioned as an add-on maintenance therapy for SEA in over 80 countries, including the United States, Japan, the European Union, and China. Additionally, it is approved for use in children and adolescents aged 6 and older in the US and Japan. In September, Fasenra gained approval for EGPA in the United States.