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FDA Approves Benralizumab for Eosinophilic Granulomatosis With Polyangiitis
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Eosinophilic granulomatosis with polyangiitis is a rare and immune-mediate vasculitis that can damage multiple organs and be fatal if left untreated.
The FDA approved benralizumab (Fasenra; AstraZeneca) for the treatment of eosinophilic granulomatosis with polyangiitis (EGPA), a rare and immune-mediate vasculitis that can damage multiple organs and be fatal if left untreated.1
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“This disease has a devastating impact on patients and the quality of their life, and they need more treatment options. The approval of another treatment in EGPA is welcome news to the approximately 15,000 patients living in the US with this difficult-to-treat rare disease,” Joyce Kullman, executive director of the Vasculitis Foundation, said in a news release.1
The approval was based on results from the MANDARA (NCT04157348) phase 3 trial, comparing the efficacy and safety of benralizumab with mepolizumab, the only approved EGPA treatment, for patients with relapsing or refractory EGPA. Investigators included individuals 18 years and older with a history or presence of asthma and eosinophilia with an EGPA diagnosis and at least 2: biopsy with eosinophilic vasculitis or perivascular/granulomatous inflammation; mono-or polyneuropathy non-fixed pulmonary infiltrates, sino-nasal abnormality; cardiomyopathy; glomerulonephritis; alveolar hemorrhaging; palpable purpura; or anti-neutrophil cytoplasmic anti-body positivity. Patients were excluded if they had a diagnosis of granulomatosis with polyangiitis or microscopic polyangiitis, had organ or life-threatening EGPA 3 months or less prior to screening, unstable liver disease, and more.1,2
Treatment included benralizumab (30 mg) as a subcutaneous injection or mepolizumab as a subcutaneous injection every 4 weeks for 52 weeks. Primary end points included proportion of patients who were in remission at both weeks 35 and 48. Secondary end points included number of patients in each category of accrued duration or remission, time from randomization to first EGPA relapse, based on the average daily prednisolone or prednisone dose during weeks 48 through 52, annualized relapse rate, remission within the first 24 weeks and remained in remission, and number of individuals with adverse events (AEs) or serious AEs.2
From October 29, 2019, to August 10, 2023, 140 individuals received randomized treatment, with 70 in each arm. Approximately 99% in the benralizumab arm completed treatment compared with 96% in the mepolizumab arm. In the population, approximately 60% were women and the mean age was 52.3 years.3
For safety, there were 90% of patients in the benralizumab group and 96% in the mepolizumab group who experienced AE. The most common reported AE was COVID-19 in 21% and 27%, respectively, headache in 17% and 16%, respectively, and arthralgia in 17% and 11%, respectively. Serious AEs were reported in 6% in the benralizumab group and 13% in the mepolizumab group, with COVID-19 being the most reported follow by prostate cancer in the mepolizumab group. There were no deaths, according to the study data.3
“This approval is great news for patients with EGPA in the US who continue to suffer from debilitating symptoms. Patients often rely on long-term oral corticosteroids, which can cause serious and lasting side effects,”Michael Wechsler, MD, MMSc, professor of Medicine and director of The Asthma Institute at National Jewish Health, said in the news release. “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.”1
