Teva's reslizumab meets primary endpoint in asthma trials

Teva Pharmaceutical Industries Ltd. (NYSE:TEVA) said IV reslizumab met the primary endpoint of reducing the frequency of clinical asthma exacerbations vs. placebo in two Phase III trials to treat severe eosinophilic asthma (p<0.0001 for both trials). The double-blind, international trials enrolled a combined 953 patients inadequately controlled by standard of care.

Next half, Teva plans to submit a BLA to FDA and an MAA to EMA for IV reslizumab, followed by submissions in Japan, Russia and emerging markets. The company also said it plans to start Phase III testing of a subcutaneous formulation of the humanized mAb against IL-5, but declined to disclose a timeline. ...