FDA Accepts Teva’s BLA for Asthma Drug
Teva Pharmaceutical Industries Ltd., reports that that the US Food and Drug Administration (FDA) has accepted for review the company’s biologics license application (BLA) for reslizumab, the company's investigational humanized monoclonal antibody, which targets interleukin-5 (IL-5), for the treatment of inadequately controlled asthma in adult and adolescent patients with elevated blood eosinophils despite an inhaled corticosteroid (ICS)-based regimen.
The BLA for reslizumab has been accepted for filing by the FDA for standard review, with FDA regulatory action expected in March 2016.
Reslizumab is an investigational humanized monoclonal antibody which targets interleukin-5 (IL-5). IL-5 is a key cytokine involved in the maturation, recruitment, and activation of eosinophils, which are inflammatory white blood cells implicated in a number of diseases, such as asthma. Elevated levels of blood eosinophils are a risk factor for future asthma exacerbations. Reslizumab binds circulating IL-5 thereby preventing IL-5 from binding to its receptor.
Source: Teva Pharmaceutical Industries