Reslizumab is the company’s investigational humanized monoclonal antibody (mAb), which targets interleukin-5 (IL-5), and is being reviewed as a potential treatment for patients with eosinophilic asthma, despite an inhaled corticosteroid (ICS)-based regimen.
The BLA is based on data from the company’s Phase III BREATH clinical trial program, which included four separate placebo-controlled Phase III trials involving over 1,700 adult and adolescent asthma patients with elevated blood eosinophils, whose symptoms were inadequately controlled with inhaled corticosteroid-based therapies.
Results from these trials showed that reslizumab, compared to placebo, reduced asthma exacerbation rates by at least half and provided significant improvement in lung function and other secondary measures of asthma control when added to an existing ICS-based therapy.
Teva Pharmaceutical Industries chief scientific officer and Global R&D president Dr Michael Hayden said: "Despite currently available medicines, uncontrolled asthma remains a serious problem for patients, physicians and healthcare systems, highlighting the need for targeted new treatment options.
"The reslizumab BLA filing acceptance represents a significant milestone for Teva as we work toward serving a specific asthma patient population that is defined by elevated blood eosinophil levels and inadequately controlled symptoms despite standard of care therapy.
"In clinical trials, patients treated with reslizumab showed significant reductions in the rate of asthma exacerbations and significant improvement in lung function.
"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."
The trials showed that the common adverse events in the reslizumab treatment group were comparable to placebo and included worsening of asthma, nasopharyngitis, upper respiratory infections, sinusitis, influenza and headache.
The BLA for reslizumab has been accepted for filing by the FDA for standard review, with FDA Regulatory Action expected in March next year.