Set-back for Sanofi's blockbuster Dupixent in urticaria

A Phase III trial (CUPID STUDY B) evaluating Dupixent (dupilumab) in patients with chronic spontaneous urticaria (CSU), who were refractory to omalizumab, will stop due to futility based on a pre-specified interim analysis, marking a rare, albeit minor, set-back for the blockbuster monoclonal antibody (MAb).

Although positive numerical trends in reducing itch and hives were observed, the results from the interim analysis did not demonstrate statistical significance for the primary endpoints, noted French pharma major Sanofi (Euronext: SAN), which markets Dupixent under a collaboration with USA-based Regeneron (Nasdaq: REGN).

The analysis was conducted by an independent interim analysis review committee. In the trial, patients who were refractory to omalizumab treatment and uncontrolled on antihistamines received Dupixent plus standard of care compared to standard of care alone for 24 weeks. The safety data were generally consistent with the known safety profile of Dupixent in its approved indications.