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ASTRAZENECA'S FASENRA RECEIVES APPROVAL IN JAPAN
ASTRAZENECA'S FASENRA RECEIVES APPROVAL IN JAPAN.
About this update from Astrazeneca Plc
[{"type":"text","content":"\n \nRNS Number : 3208C AstraZeneca PLC 19 January 2018 \n\n19 January 2018 07:00 GMT\n \nFASENRA RECEIVES APPROVAL IN JAPAN \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 approved respiratory biologic with an 8-week \nmaintenance dosing schedule\n \nAstraZeneca and its global biologics research and development arm, MedImmune, today announced that the Japanese Ministry of Health, Labour and Welfare has approved Fasenra (benralizumab) as an add-on treatment for bronchial asthma in patients who continue to experience asthma exacerbations despite treatment with high-dose inhaled corticosteroid and other asthma controllers.\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 oral corticosteroid (OCS)-sparing trial, ZONDA.1 Fasenra will be available as a fixed-dose subcutaneous injection in a prefilled syringe administered once every four weeks for the first three doses, and then once every eight weeks thereafter.1\n \nSean Bohen, Executive Vice President, Global Medicines Development and Chief Medical Officer at AstraZeneca, said: \"The approval of Fasenra, our first respiratory biologic medicine, in Japan closely follows the recent US and EU decisions and brings us another step closer to achieving our ambition of transforming care for severe asthma patients around the world.\"\n \nFasenra binds directly to the IL-5α receptor on eosinophils, a type of white blood cell that are a normal part of the body's immune system,2 and attracts natural killer cells to induce direct, rapid and near-complete depletion of eosinophils via apoptosis (programmed cell death).5,6,7 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 and increased risk of exacerbations.3,4 \n \nThe Japanese approval follows US FDA approval in November 2017 and European Commission marketing authorisation in January 2018. Interactions with regulatory authoritie...