BRIEF—Dupixent trial scores hat-trick in asthma

A Phase III study of Dupixent (dupilumab) in severe, steroid-dependent asthma met not only the primary endpoint but also two key secondary endpoints, Sanofi and Regeneron have announced.

For the primary endpoint, at 24 weeks in the overall population, dupilumab added to standard therapies significantly reduced the use of maintenance oral corticosteroids (OCS) by 70% on average compared to 42% with placebo.

Dupilumab delivered on the secondary endpoints by reducing asthma attacks, despite the lower usage of OCS, and improving lung function. Its safety and tolerability profile was consistent with previous studies.

VENTURE is the third trial in the uncontrolled persistent asthma pivotal clinical program and follows positive results from the Phase III QUEST study and Phase IIb pivotal study of dupilumab. The companies plan to submit a Supplemental Biologics License Application to the US Food and Drug Administration by the end of this year.