Sanofi (Euronext:SAN; NYSE:SNY) and Regeneron Pharmaceuticals Inc. (NASDAQ:REGN) reported top-line data from the Phase III LIBERTY ASTHMA QUEST trial in 1,902 patients with uncontrolled, persistent asthma showing that Dupixent dupilumab (REGN668, SAR231893) met the co-primary endpoints vs. placebo.
On the co-primary exacerbation endpoint, 300 mg subcutaneous Dupixent reduced the annual rate of severe asthma attacks at week 52 by 46% vs. placebo in the overall population (p<0.001). The prespecified primary analysis included a hierarchical evaluation of the endpoints in the overall population, in patients with 150 eosinophilic cells/µL or greater, and in patients with 300 eosinophilic cells/µL or greater. In patients with at least 150 and 300 eosinophilic cells/µL, 300 mg Dupixent reduced the annual rate of severe asthma attacks by 60% and 67%, respectively, vs. placebo (p<0.001 for both)...