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Teva’s new asthma therapy reslizumab accepted for EU review
Teva has announced that its new asthma therapy reslizumab has been accepted for European regulatory review.
The company has successfully filed a marketing authorisation application with the European Medicines Agency for the humanised anti-interleukin-5 monoclonal antibody, which is intended for the treatment of inadequately controlled asthma in adult patients with elevated blood eosinophils, despite an inhaled corticosteroid-based regimen.
Data from Teva's phase III BREATH clinical trial programme has shown that the drug can reduce asthma exacerbation rates by at least half and provide significant improvement in lung function and quality of life compared to placebo.
A final decision on reslizumab is anticipated from the European Commission in the second half of 2016.
Dr Michael Hayden, president of global research and development and chief scientific officer at Teva Pharmaceutical Industries, said: "The successful filing of the marketing authorisation application for reslizumab means that this patient population, which often experiences the most severe symptoms, is now one step closer to a new targeted treatment option in Europe."
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