FDA OKs New Option for Rare Immune-Mediated Vasculitis

The FDA approved the asthma drug benralizumab (Fasenra) as a new therapy for adults with eosinophilic granulomatosis with polyangiitis (EGPA), drugmaker AstraZeneca announced on Wednesday.

EGPA, previously known as Churg-Strauss syndrome, is a rare inflammatory disorder characterized by asthma, necrotizing vasculitis, extravascular granulomas, and blood and tissue eosinophilia. The rare immune-mediated vasculitis is caused by inflammation of blood vessels that can damage multiple organs and be fatal if left untreated.

Support for the monthly subcutaneous injection came from the MANDARA trial, which involved 140 patients with relapsing or refractory EGPA and compared benralizumab with mepolizumab (Nucala) atop standard therapy, which historically has involved oral corticosteroids or other immunosuppressants like azathioprine or cyclophosphamide. Until now, mepolizumab had been the only approved treatment for EGPA.

The phase III study demonstrated benralizumab’s noninferiority, with 59% of patients achieving remission with the interleukin (IL)-5 receptor alpha-directed cytolytic monoclonal antibody versus 56% of those assigned to the IL-5 antagonist mepolizumab, with remission defined as a Birmingham Vasculitis Activity Score of 0 and oral corticosteroid dosing of no more than 4 mg per day.

More patients treated with benralizumab were able to fully taper off oral corticosteroids during the trial as well (41% vs 26% in the mepolizumab arm).

“This approval is great news for patients with EGPA in the U.S. who continue to suffer from debilitating symptoms,” MANDARA investigator Michael Wechsler, MD, of the Asthma Institute at National Jewish Health in Denver, said in a statement.

“Patients often rely on long-term oral corticosteroids, which can cause serious and lasting side effects,” Wechsler continued. “Benralizumab is a much-needed treatment option, with data showing that not only is remission an achievable goal for EGPA patients, but benralizumab can also help patients taper off steroid therapy.”

Beyond the side effects, patients attempting to taper off long-term oral corticosteroids often cannot do so without disease relapse.

Adverse event (AE) data from MANDARA proved consistent with the known safety profile of benralizumab, according to AstraZeneca. Labeling for the drug notes headache and pharyngitis as the most common AEs in trials, occurring in 5% or more of patients.

Benralizumab was first approved in 2017 for treating severe eosinophilic asthma in individuals 12 years and older, which has since been expanded to children as young as 6 years.

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