AstraZeneca’s Fasenra scores US approval in severe asthma
pharmafile | November 15, 2017 | News story | Research and Development, Sales and Marketing | AstraZeneca, Fasenra, MedImmune, asthma
AstraZeneca and MedImmune, the company’s biologics research and development division, have revealed the decision by the FDA to approve Fasenra (benralizumab) in the US as an add-on treatment for severe asthma in patients over 12 with an eosinophilic phenotype.
The regulator’s decision was based on results of a programme which included Phase 3 exacerbation and oral-corticosteroid-sparring (OCS) trials. The findings demonstrated that an eight-week dosing regimen produced an up to 51% reduction in annual asthma exacerbation rates compared to placebo, in addition to a “significant improvement” in lung function, as measured by forced expiratory volume in one second (FEV1) of up to 159mL. Median reduction in daily OCS stood at 75% and discontinuation of OCS use was 52% in eligible patients.
“This is an important day for severe, eosinophilic asthma patients who have had limited treatment options for far too long, with many relying on oral steroids to manage their symptoms,” said Eugene Bleecker, Professor and Co-Director, Genetics, Genomics and Precision Medicine, University of Arizona Health Sciences, and lead investigator of the Phase III SIROCCO study. “Fasenra has a strong clinical profile which includes the ability to show lung function improvement after the first dose, the potential to reduce – or even stop – oral steroid use, and the convenience of eight-week dosing. Fasenra also treats a distinct patient phenotype, helping physicians select the right patient in clinical practice with more confidence.”
The only respiratory biologic that provides “direct, rapid and near-complete depletion of eosinophils within 24 hours”, according to the manufacturer, Fasenra operates by binding directly to the IL-5α receptor on an eosinophil, which attracts the body’s immune cells to trigger programmed cell death.
Pascal Soriot, Chief Executive Officer of AstraZeneca, also commented: “We’re excited to offer Fasenra as a new precision biologic to help improve the lives of severe asthma patients whose disease is driven by eosinophilic inflammation. This is the first approval from our respiratory biologics portfolio and the latest in a series of significant milestones for our company as we deliver on our pipeline-driven transformation.”
Matt Fellows
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