FDA Approves New Option for Severe Eosinophilic Asthma
The FDA has approved Fasenra (benralizumab) for the add-on maintenance treatment of patients with severe asthma and an eosinophilic phenotype aged 12 years or older.
The approval was based on the results of the WINDWARD program, which included Phase 3 exacerbation trials and a Phase 3 oral corticosteroid-sparing trial. The trials showed that patients assigned to an 8-week benralizumab dosing regimen experienced up to a 51% reduction in annual asthma exacerbation rate, compared with placebo, significant improvement in lung function as measured by forced expiratory volume in one second compared with placebo, and a 75% median reduction in daily oral corticosteroid use and a discontinuation of oral corticosteroid use in 52% of eligible patients.
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Those taking benralizumab had a similar adverse event profile to those taking placebo.
Fasenra will be available as a once every 8-week fixed-dose subcutaneous injection via prefilled syringe.
Fasenra (benralizumab) receives US FDA approval for severe eosinophilic asthma [press release]. AstraZeneca. November 14, 2017. https://www.astrazeneca.com/media-centre/press-releases/2017/fasenra-benralizumab-receives-us-fda-approval-for-severe-uncontrolled-eosinophilic-asthma-14112017.html.