Regeneron and Sanofi's Dupixent successful in late-stage asthma study

Oct. 31, 2017 7:25 AM ETRegeneron Pharmaceuticals, Inc. (REGN)By: Douglas W. House, SA News Editor4 Comments
  • A Phase 3 clinical trial, LIBERTY ASTHMA VENTURE, evaluating Regeneron Pharmaceuticals (NASDAQ:REGN) and Sanofi's (SNY) DUPIXENT (dupilumab) in adults and adolescents with severe steroid-dependent asthma met its primary endpoint and key secondary endpoints.
  • At week 24, dupilumab plus standard therapies statistically significantly reduced the use of maintenance oral corticosteroids by an average of 70% and a median of 100% compared 42% and 50%, respectively, for placebo (p<0.0001). In patients with baseline eosinophil counts at least 300 cells/microliter, the reductions were 80% and 100%, respectively, compared to placebo's 43% and 50% (p=0.0001).
  • At week 24, patients receiving dupilumab experienced 59% fewer asthma attacks than placebo (overall population) while those with eosinophil counts at least 300 cells/microliter experienced 71% fewer attacks. Treatment with dupilumab also resulted in a 15% improvement in lung function in the overall population and a 25% improvement in patients with elevated eosinophil counts (at least 300 cells/microliter).
  • Dupilumab's safety profile was consistent with earlier studies.
  • A U.S. marketing application is on tap this quarter. DUPIXENT is currently approved in the U.S. and EU for moderate-to-severe atopic dermatitis.

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