Fasenra OK’d for Rare Vasculitis

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, 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.