Reslizumab: Phase III data

A double-blind, U.S. Phase III trial in 492 patients aged 18-65 years with uncontrolled moderate to severe asthma showed that 3 mg/kg IV reslizumab given once every 4 weeks for 16 weeks improved FEV1, the primary endpoint, compared to placebo in the overall population by 68 mL, in patients with sputum eosinophils of >=400/UL by 270 mL (p=0.04) and in patients with sputum eosinophils of <400/UL by 33 mL. Teva said the data support the company's eosinophil threshold of >=400/UL for its Phase III program of reslizumab. Reslizumab also reduced rescue medication vs. placebo by 0.708 inhalations/day in patients with sputum eosinophils of >=400/UL. Data were presented at the European Respiratory Society meeting in Munich. ...