Advisory Committee recommends reslizumab to treat asthma in patients with elevated blood eosinophils -Teva

Teva Pharmaceutical Industries Ltd.) announced that the FDA Pulmonary-Allergy Drugs Advisory Committee recommended approval (11-3) of reslizumab, a humanized anti-interleukin-5 (IL-5) IgG4K monoclonal antibody (mAb), in adult patients aged 18 years and older. Reslizumab is an injectable, targeted biologic therapy for the treatment of inadequately controlled asthma in patients with elevated blood eosinophils,despite an inhaled corticosteroid (ICS)-based treatment regimen. The Advisory Committee's recommendation will be considered by the FDA in its review of the Biologics License Application (BLA) for reslizumab. The FDA is not bound by the Committee's recommendation, but takes its advice into consideration when reviewing investigational medicines. The reslizumab BLA was accepted for standard review by the FDA and Regulatory Action is expected in March 2016. Additional regulatory filings for reslizumab have been completed in the EU and Canada.

Comment: The FDA Advisory Committee did not extend the scope of reslizumab to adolescents due to insufficient data.