Teva Files Asthma Biologic With EMA
Teva Pharmaceutical Industries Ltd., has successfully filed a marketing authorization application (MAA) with the European Medicines Agency (EMA) for reslizumab, a humanized anti-interleukin-5 (IL-5) monoclonal antibody for treating asthma. The drug is specifically targeted for treating 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. A biologics license application for reslizumab was also accepted by the US Food and Drug Administration (FDA) in June 2015, with FDA regulatory action expected in March 2016.
Reslizumab is an investigational humanized monoclonal antibody developed to target interleukin-5 (IL-5). IL-5 is a cytokine shown to play a role in the maturation, activation, and survival of eosinophils, which are a type of white blood cell that are present at elevated levels in the lungs and blood of many asthmatics. Evidence shows that eosinophils play a role in the pathogenesis of the disease. Increased levels of eosinophils in the sputum and blood have been shown to positively correlate with disease severity and increased risk of asthma exacerbations. Reslizumab acts by binding circulating IL-5 and preventing IL-5 from interacting with its receptor, according to information from Teva.