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AstraZeneca's Fasenra approved in the EU
AstraZeneca's Fasenra approved in the EU.
About this update from Astrazeneca Plc
[{"type":"text","content":"\n \nRNS Number : 5204B AstraZeneca PLC 10 January 2018 \n\n \n10 January 2018 15:10 GMT\n \nFASENRA RECEIVES EU APPROVAL FOR SEVERE EOSINOPHILIC ASTHMA\n \nApproval based on Phase III WINDWARD programme that demonstrated significant reductions in asthma exacerbations, improvements in lung function and reductions in oral corticosteroid use from baseline, versus placebo\n \nFasenra is the first-ever approved respiratory biologic medicine with an 8-week maintenance dosing schedule\n \nAstraZeneca and its global biologics research and development arm, MedImmune, today announced that the European Commission (EC) has approved Fasenra (benralizumab) as an add-on maintenance treatment in adult patients with severe eosinophilic asthma inadequately controlled despite high-dose inhaled corticosteroids plus long-acting beta-agonists.1 \n \nThe approval is based on the results from the WINDWARD programme, including the pivotal Phase III exacerbation trials, SIROCCO and CALIMA, and the Phase III OCS-sparing trial, ZONDA.1\n \nSean Bohen, Executive Vice President, Global Medicines Development and Chief Medical Officer at AstraZeneca, said: \"Fasenra is our first respiratory biologic medicine. Today's decision from the EC follows the recent approval of Fasenra in the US and is another positive step towards our ambition to transform care for severe asthma patients whose disease is driven by eosinophilic inflammation.\"\n \nTim Harrison, Professor of Asthma and Respiratory Medicine, University of Nottingham, UK, and investigator in the WINDWARD trial programme, said: \"Many patients with severe eosinophilic asthma experience debilitating symptoms and face increased risk of emergency room visits, hospitalisations and death, despite current treatments. I look forward to being able to offer Fasenra as a new anti-eosinophilic monoclonal antibody which has demonstrated efficacy versus placebo in pivotal clinical trials and has the convenience of an 8-week maintenance dosing regimen.\"\n \nEosinophils are a type of white blood cell that are a normal part of the body's immune system.2 Elevated levels of eosinophils, seen in about half of severe asthma patients, impact airway inflammation and airway hyper-responsiveness, resulting in increased asthma severity and symptoms, decreased lung function a...