EMA accepts MAA for Cinquil (reslizumab) for the treatment of inadequately controlled asthma in adult patients with elevated blood eosinophils- Teva
Teva Pharmaceutical Industries Ltd. announced that it has successfully filed a Marketing Authorization Application (MAA) with the European Medicines Agency (EMA) for Cinquil (reslizumab). Reslizumab is a humanised anti-interleukin-5 (IL-5) monoclonal antibody (mAb) for the treatment of inadequately controlled asthma in adult patients with elevated blood eosinophils, despite an inhaled corticosteroid (ICS)-based regimen.
A final decision from the EMA on reslizumab is anticipated in the second half of 2016.
Comment: the FDA has accepted for review the Biologics License Application (BLA) for reslizumab, for the treatment of inadequately controlled asthma in adult and adolescent patients with elevated blood eosinophils, despite an ICS-based regimen.
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