The U.S. FDA has granted Orphan Drug Designation (ODD) to Fasenra (benralizumab) for the treatment of hypereosinophilic syndrome.
The designation comes on the back of data from a phase II trial conducted by the United Sates National Institutes of Health in collaboration with AstraZeneca, with the results expected to be published later this year.
In the trial, Fasenra depleted blood eosinophils at week 12 compared with placebo, with evidence of eosinophil clearance in affected tissue at week 24.
Fasenra itself is a monoclonal antibody that binds directly to IL-5 receptor α on eosinophils and attracts natural killer cells to induce rapid and near-complete depletion of eosinophils via apoptosis (programmed cell death)
Mene Pangalos, executive VP, R&D Biopharmaceuticals, said: “In patients with hypereosinophilic syndrome, high levels of eosinophils contribute to a range of debilitating symptoms and can even lead to life-threatening organ damage.
“Based on results from the phase II trial, we believe Fasenra has the potential to address critical unmet medical needs in patients living with hypereosinophilic syndrome.”
Currently speaking, Fasenra is AstraZeneca’s first respiratory biologic and is currently approved for eosinophilic asthma in the US, EU, Japan and several other countries.