The FDA is currently reviewing Teva's reslizumab treatment for adult and adolescent asthmatics with symptoms inadequately controlled by inhaled corticosteroid (ICS) regimens.
The FDA is currently reviewing Teva’s reslizumab treatment for adult and adolescent asthmatics with symptoms inadequately controlled by inhaled corticosteroid (ICS) regimens.
“Despite currently available medicines, uncontrolled asthma remains a serious problem for patients, physicians, and health care systems, highlighting the need for targeted new treatment options,” stated Teva’s president of global R&D and chief scientific officer, Michael Hayden. “If approved, we believe reslizumab will serve as an important new targeted treatment option to achieve better asthma control for patients with eosinophil-mediated disease.”
Reslizumab is an investigational humanized monoclonal antibody that targets interleukin-5, a key cytokine involved in elevating levels of blood eosinophils, which can raise the risk for asthma exacerbations. Without adequate treatment, asthma symptoms may become severe enough to lead to hospitalization and even death.
Reslizumab’s Biologics License Application (BLA) is based on the results of its phase 3 BREATH program, which demonstrated that it reduced asthma exacerbation rates by at least half and significantly improved lung function and other measures of asthma control when added to an existing ICS-based regimen, compared with placebo.
Common side effects observed in reslizumab-treated study subjects were worsening asthma, nasopharyngitis, upper respiratory tract infections, influenza, and headaches, but they were all comparable to placebo.
The FDA is expected to act on reslizumab’s BLA in March 2016.