FDA to review Teva asthma biologic
- The FDA will be reviewing Teva's investigational interleukin-5 (IL-5) drug, reslizumab, for treatment of eosinophilic asthma.
- Reslizumab is a humanized monoclonal antibody, which targets interleukin-5.
- In clinical trials, reslizumab cut asthma exacerbation rates by at least 50%, with significant improvements in lung function.
The goal of gaining approval for reslizumab is to bring another IL-5 drug---part of a new class of asthma drugs, including the recently approved mepolizumab from GSK---into the treatment armamentarium for ashtma.
Reslizumab is intended to be used in conjunction with an inhaled corticosteroid (ICS) in patients who are not properly controlled on an ICS, and frequently rely on rescue therapy.
- Pharma Times FDA will review Teva's asthma biologic reslizumab