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# Fasenra OK’d for Rare Vasculitis
- URL: https://www.fdaweb.com/fasenra-okd-for-rare-vasculitis/
- Published: 2024-09-18T12:00:00.000Z
- Updated: 2026-09-14T14:41:35.000Z
- Author: David McFarland
- Tags: Biologics, #legacy-id-D5157810

FDA has approved AstraZeneca’s Fasenra (benralizumab) for treating adult patients with eosinophilic granulomatosis with polyangiitis (EGPA), a rare immune-mediated vasculitis that can result in damage to multiple organs.

The approval was based on data from the noninferiority MANDARA Phase 3 trial published in [*The New England Journal of Medicine*](https://www.nejm.org/stoken/default+domain/REPRINTS%5F36237/full?redirectUri=/doi/full/10.1056/NEJMoa2311155&ref=fdaweb.com), which compared Fasenra to GSK’s Nucala (mepolizumab) in patients with relapsing or refractory EGPA. “In the trial, nearly 60% of Fasenra*\-*treated patients achieved remission which was comparable to mepolizumab-treated patients,” AstraZeneca says. “Data also showed 41% of Fasenra*\-*treated patients fully tapered off oral corticosteroids vs. 26% in the mepolizumab arm….”

The drug was first approved in 2017 as an add-on maintenance therapy for severe eosinophilic asthma in patients aged 12 years and older. Earlier this year, FDA approved a supplemental BLA for Fasenra as an add-on maintenance treatment for patients with severe asthma aged six to 11 years with an eosinophilic phenotype.