Sanofi and Regeneron’s blockbuster drug Dupixent successfully treated patients with chronic spontaneous urticaria, an inflammatory skin disease, in a late-stage trial, the companies announced on Wednesday, bringing the firms closer to securing Food and Drug Administration approval after the agency rejected their application last year.
In the Phase 3 trial, dubbed Liberty-Cupid Study C, patients took antihistamines, the current standard of care, and Dupixent or a placebo. After six months of treatment, those on Dupixent had an 8.64-point reduction in itch severity compared to baseline, while those on placebo had a 6.10-point reduction. Similarly, participants on Dupixent had a 15.86-point reduction in itchy, irritating hives while those on the placebo had an 11.21-point reduction.
Both of these differences were statistically significant, as was the observation that 30% of Dupixent-treated patients had a complete response to treatment, leaving them hive- and itch-free, compared to 18% of those taking the placebo. And the therapy was generally safe, with identical adverse event rates of 53% in those taking Dupixent or placebo.
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