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BENRALIZUMAB POSITIVE CHMP IN EOSINOPHILIC ASTHMA
BENRALIZUMAB POSITIVE CHMP IN EOSINOPHILIC ASTHMA.
About this update from Astrazeneca Plc
[{"type":"text","content":"\n \nRNS Number : 1876W AstraZeneca PLC 10 November 2017 \n\nThis announcement contains inside information\n \n10 November 2017 11:35 GMT\n \nBENRALIZUMAB RECEIVES POSITIVE EU CHMP OPINION\nFOR SEVERE, UNCONTROLLED EOSINOPHILIC ASTHMA \n \nBenralizumab uniquely targets and rapidly depletes eosinophils and is the first respiratory biologic with an 8-week maintenance dosing schedule \n \nRecommendation based on extensive Phase III programme demonstrating significant reductions in exacerbations, improvements in lung function and reductions in oral steroid use, respectively\n \nAstraZeneca and its global biologics research and development arm, MedImmune, today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has adopted a positive opinion, recommending the marketing authorisation of benralizumab as an add-on maintenance treatment in adult patients with severe eosinophilic asthma inadequately controlled despite high-dose inhaled corticosteroids plus long-acting b-agonists.\n \nSean Bohen, Executive Vice President, Global Medicines Development and Chief Medical Officer at AstraZeneca, said: \"This positive recommendation is an important step towards providing a next-generation treatment for severe, uncontrolled asthma patients with an eosinophilic phenotype. Benralizumab has the potential to make a real difference to patients with its combination of efficacy, speed of onset, convenience and the ability to reduce oral steroid use.\"\n \nThe CHMP recommendation is based on results from the WINDWARD programme, including the pivotal Phase III exacerbation trials, SIROCCO and CALIMA, and Phase III oral corticosteroid (OCS)-sparing trial, ZONDA. Results for the 8-week dosing benralizumab regimen from these trials showed: \n \n· Up to 51% reduction in the annual asthma exacerbations rate (AERR) versus placebo \n· Rapid improvement in lung function (290mL increase in forced expiratory volume in one second (FEV1) from baseline at 4 weeks) after the first dose, providing an early indication of effectiveness\n· 75% median reduction in daily OCS use and discontinuation of OCS use in 52% of eligible patients \n· ...