Fasenra Approved in EU for Eosinophilic Granulomatosis with Polyangiitis
Key Insights
AstraZeneca's Fasenra (benralizumab) has been approved in the EU for treating adults with eosinophilic granulomatosis with polyangiitis (search) (EGPA).
The approval was based on the Phase III MANDARA trial, where nearly 60% of Fasenra-treated patients achieved remission.
41% of patients on Fasenra successfully tapered off oral corticosteroids, compared to 26% in the comparator arm.
AstraZeneca's Fasenra (benralizumab) has received approval from the European Commission as an add-on treatment for adult patients with eosinophilic granulomatosis with polyangiitis (search) (EGPA), a rare and potentially fatal immune condition characterized by organ damage. This approval marks a significant advancement in the treatment landscape for EGPA, offering a new therapeutic option for patients in the EU.
The approval is based on the positive outcomes of the Phase III MANDARA trial, a head-to-head non-inferiority study comparing Fasenra to mepolizumab. The results, published in The New England Journal of Medicine, demonstrated that nearly 60% of patients treated with Fasenra achieved remission. Furthermore, 41% of patients in the Fasenra arm were able to completely discontinue oral corticosteroids (OCS), compared to 26% in the comparator arm (difference: 16%; 95% CI: 1,31).
Clinical Impact and Expert Opinion
Bernhard Hellmich, co-director of the Vasculitis Center Tübingen-Kirchhei and principal investigator of the MANDARA trial, emphasized the importance of this approval: "People living with EGPA suffer debilitating symptoms, organ damage and even death. Today’s approval provides an important treatment option for people living with EGPA in the EU...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."
The MANDARA Trial: Key Details
The MANDARA trial randomized patients to receive either a 30 mg subcutaneous injection of Fasenra monthly or three separate 100 mg subcutaneous injections of mepolizumab every four weeks. The study was designed to assess the efficacy and safety of Fasenra in patients with EGPA. The primary endpoint focused on remission rates and the ability to reduce or eliminate OCS use.
The safety and tolerability profile of Fasenra in the MANDARA trial was consistent with its established profile. Approximately half of EGPA patients also have adult-onset severe eosinophilic asthma (search) (SEA) and often experience sinus and nasal symptoms. Fasenra is already approved for SEA in over 80 countries, including the US, Japan, and China, and was approved for EGPA in the US in September.
Current Treatment Landscape and Unmet Needs
EGPA is a rare disease where the underlying cause is not well understood. Current treatments often involve corticosteroids, which can have significant side effects. Fasenra's approval provides a targeted biologic therapy that directly addresses eosinophilic inflammation, potentially reducing the need for high-dose corticosteroids and improving patient outcomes. Ruud Dobber, executive vice president, BioPharmaceuticals Business Unit, AstraZeneca, stated, "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 (search) and we are pleased to now offer a much-needed treatment option for those living with EGPA in Europe."