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The Discovery Centre with AstraZeneca signage. (Credit: David Porter/AstraZeneca)

NICE recommends Benralizumab for Rare Form of Vasculitis

Ella Day | August 15, 2025 | News story | Medical Communications, Research and Development AstraZeneca, Immunology, National Institute for Health and Care Excellence, vasculitis 

The National Institute for Health and Care Excellence (NICE) has recommended AstraZeneca’s benralizumab (Fasenra) as an add-on treatment for adult patients with relapsing or refractory eosinophilic granulomatosis with polyangiitis (EGPA). This marks the first NHS-funded biologic treatment option for eligible patients in England, with interim funding allowing immediate access.

The recommendation is based on results from Astrazeneca’s phase 3 trial, which compared benralizumab with mepolizumab – the only other biologic for EGPA licensed in the UK. Enrolling 140 patients across 52 weeks, assessing remission at weeks 36 and 48 as the primary endpoint and steroid withdrawal as a secondary measure.

Results showed that benralizumab was non-inferior to mepolizumab in achieving remission, with nearly 60% of patients in the benralizumab group reaching remission and around 40% tapering completely off oral corticosteroids. The safety profile was consistent with existing data.

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EGPA is a rare immune-mediated form of vasculitis that can damage multiple organs and significantly impact daily functioning. In England, it affects approximately 2,600 people. Conventional treatments often rely on oral corticosteroids, which can have long-term side effects.

“Living with relapsing or refractory EGPA has a profound impact on quality of life,” said Claire Tolliday, chair of Vasculitis UK. “Today’s decision marks an important milestone for patients with EGPA.”

Ella Day

15/8/25

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