EC Approves Fasenra for EGPA Treatment

The European Commission (EC) has granted approval for AstraZeneca's Fasenra (benralizumab) as an add-on therapy for adult patients with relapsing or refractory eosinophilic granulomatosis with polyangiitis (EGPA), which was previously known as Churg-Strauss syndrome. This makes Fasenra the second biologic therapy approved for treating this condition.

Fasenra's approval was based on a recommendation from the Committee for Medicinal Products for Human Use (CHMP) and supported by findings from the MANDARA Phase III clinical trial. EGPA is a rare form of vasculitis that causes inflammation in small to medium-sized blood vessels, potentially leading to damage in multiple organs. If left untreated, EGPA can be dangerous.

Nearly half of individuals with EGPA also suffer from severe eosinophilic asthma, and they frequently have sinus and nasal issues. The approval of Fasenra provides a new treatment option for these patients, presenting a significant advancement in managing the disease.

Ruud Dobber, Executive Vice President of AstraZeneca's BioPharmaceuticals Business Unit, expressed optimism following the approval. He emphasized that Fasenra, administered as a single monthly injection, represents a significant step forward for EGPA patients. He also noted that Fasenra has been a trusted treatment for severe eosinophilic asthma for many years, and its extension to EGPA offers a much-needed therapeutic option in Europe.

The approval follows results from the MANDARA study, a randomized, double-blinded, active-controlled clinical trial that assessed the efficacy and safety of Fasenra compared to mepolizumab in adults with relapsing or refractory EGPA. This trial was notable for being the first head-to-head non-inferiority study of biologics in this patient group.

In the trial, 140 patients were randomized in a 1:1 ratio to receive either a single 30mg subcutaneous injection of Fasenra or three separate 100mg subcutaneous injections of mepolizumab every four weeks. The results indicated that nearly 60% of patients treated with Fasenra achieved remission, a rate comparable to those treated with mepolizumab. Additionally, 41% of patients taking Fasenra were able to stop using oral corticosteroids (OCS) altogether.

The safety and tolerability profiles observed in the MANDARA trial aligned with Fasenra's known characteristics, affirming its suitability for EGPA treatment.

AstraZeneca developed Fasenra with licensing from BioWa, a subsidiary of Kyowa Kirin. Currently, Fasenra is approved for use in over 80 countries and regions, including Japan, the United States, the European Union, and China. This widespread approval underscores the global recognition of Fasenra's efficacy and safety in treating severe eosinophilic asthma and now, EGPA. The introduction of Fasenra for EGPA patients in Europe marks a pivotal development in the therapeutic landscape for this challenging condition.