AstraZeneca announced that it gained FDA approval of Fasenra (benralizumab) for the add-on maintenance treatment of patients with severe asthma aged 12 years and older, and with an eosinophilic phenotype. The company noted that the monoclonal antibody, which was in-licensed from Kyowa Hakko Kirin's BioWa subsidiary, will be available in the US within the coming weeks.
CEO Pascal Soriot remarked "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." Soriot added "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."
Approval of Fasenra is based on data from the WINDWARD programme, which included the pivotal Phase III exacerbation trials, SIROCCO and CALIMA, and the late-stage oral corticosteroid-sparing study, ZONDA. Results for the 8-week dosing regimen from these trials showed up to a 51-percent reduction in the annual asthma exacerbation rate for Fasenra versus placebo, as well as a significant improvement in lung function, as measured by forced expiratory volume in one second, of up to 159 mL compared to placebo.
FirstWord reports in this therapy area - KOL Insight Targeted Therapies in Asthma: Find out how KOLs expect the market to evolve, which pipeline treatments are most promising, and which clinical trials will shape treatment decisions. Learn more.
According to AstraZeneca, treatment with Fasenra in the first year will cost $38 000, which the company said was as in line with other injectable antibody drugs for severe asthma, such as GlaxoSmithKline's Nucala (mepolizumab) and Teva's Cinqair (reslizumab). AstraZeneca added that long term, the price of Fasenra will be $28 000, or $33 000 in a maintenance year, depending on whether patients receive six or seven doses.
Earlier this month, the European Medicines Agency's Committee for Medicinal Products for Human Use adopted a positive opinion recommending the approval of benralizumab. Regulatory filings for the therapy, which binds directly to the IL-5 alpha receptor on eosinophils, are under review in several other countries including Japan.
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