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AZ Fasenra receives FDA approval for severe asthma
AZ Fasenra receives FDA approval for severe asthma.
About this update from Astrazeneca Plc
[{"type":"text","content":"\n \nRNS Number : 5114W AstraZeneca PLC 14 November 2017 \n\nThis announcement contains inside information\n \n14 November 2017 22:45 GMT\n \nFASENRA (BENRALIZUMAB) RECEIVES US FDA APPROVAL\nFOR SEVERE EOSINOPHILIC ASTHMA\n\nFasenra distinctively targets and rapidly depletes eosinophils and is the first respiratory biologic with an 8-week maintenance dosing schedule\n \nFDA approval based on Phase III programme demonstrating up to 51% reduction in asthma exacerbations, significant improvement in lung function and a 75% reduction in daily oral steroid use\n \nAstraZeneca and its global biologics research and development arm, MedImmune, today announced that the US Food and Drug Administration (FDA) has approved Fasenra (benralizumab) for the add-on maintenance treatment of patients with severe asthma aged 12 years and older, and with an eosinophilic phenotype.\n \nPascal Soriot, Chief Executive Officer of AstraZeneca, said: \"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.\"\n \nThe FDA approval is based on results from the WINDWARD programme, including the pivotal Phase III exacerbation trials, SIROCCO and CALIMA, and the Phase III oral corticosteroid (OCS)-sparing trial, ZONDA. Results for the 8-week benralizumab dosing regimen from these trials showed: \n \n· Up to 51% reduction i...