Teva Pharmaceutical Industries Ltd., a leading global pharmaceutical company, recently announced that the FDA has accepted reslizumab, the company’s investigational drug, for review for the Biologics License Application (BLA). The drug is a humanized monoclonal antibody (mAb) that is able to target interleukin-5 (IL-5),). Reslizumab is being developed as treatment of inadequately controlled asthma in adults and young people who have increased blood eosinophils, despite being under treatment with an inhaled corticosteroid (ICS) drug regimen.
“Despite currently available medicines, uncontrolled asthma remains a serious problem for patients, physicians and healthcare systems, highlighting the need for targeted new treatment options,” said Dr. Michael Hayden, President of Global R&D and Chief Scientific Officer at Teva Pharmaceutical Industries Ltd. “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 Biologics License Application includes results from the company’s’ Phase III clinical trial program called BREATH. BREATH involves four different placebo-controlled Phase III clinical trials that included about 1,700 adult and young people with asthma who had increased levels of eosinophils, and whose asthma symptoms were inefficiently controlled with the use of inhaled corticosteroids.
Results from both trials showed that in comparison with the placebo, reslizumab was able to reduce the rates of asthma exacerbation by at least half. The therapy was also found to improve lung function and other asthma parameters when used in addition to ICS-based therapy.
In terms of adverse events, patients in the treatment arm of the study had similar symptoms to the patients in the placebo group. These events involved influenza, nasopharyngitis, sinusitis, worsening of asthma, upper respiratory infections and headache.
The results of the program were presented during the 2015 Annual Meeting of the American Thoracic Society and at the 2015 Annual Meeting of the American Academy of Allergy, Asthma and Immunology. BREATH results are published in the journal The Lancet Respiratory Medicine. The BLA for reslizumab has been accepted for filing by the FDA for standard review, with FDA Regulatory Action expected in March 2016.
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