Sanofi and Regeneron's Dupixent succeeds in trial of chronic hives - STAT News
Sanofi and Regeneron's Dupixent showed significant improvement in chronic spontaneous urticaria patients in a Phase 3 trial, with 30% achieving complete response versus 18% on placebo, moving closer to FDA approval.
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Sanofi's Phase III LIBERTY-CUPID Study C of Dupixent in chronic spontaneous urticaria met primary and key secondary endpoints, showing significant reductions in itch and hives at 24 weeks. Dupixent, when added to antihistamines, demonstrated better efficacy than placebo, with 30% of patients reporting no urticaria. Safety results aligned with Dupixent's known profile, with treatment-emergent adverse events observed at similar rates for both Dupixent and placebo.
Phase 3 LIBERTY-CUPID Study C for dupilumab in chronic spontaneous urticaria (CSU) met primary and secondary endpoints, showing dupilumab significantly reduced itch and hives compared to placebo. Dupilumab achieved a 30% complete response rate versus 18% for placebo by week 24, with equivalent adverse event rates. These results support dupilumab's potential as a targeted therapy for CSU, pending FDA approval.
Dupixent (dupilumab) showed significant potential in treating chronic spontaneous urticaria (CSU) in biologic-naïve patients unresponsive to antihistamines, reducing itch and urticaria activity scores by 50% compared to placebo in the LIBERTY-CUPID Study C. The safety profile of Dupixent remained consistent with previous findings, and the study results are expected to be submitted to the FDA by the end of the year.
Sanofi and Regeneron's Dupixent showed significant improvement in chronic spontaneous urticaria patients in a Phase 3 trial, with 30% achieving complete response versus 18% on placebo, moving closer to FDA approval.
Sanofi and Regeneron plan to resubmit an FDA application for Dupixent in chronic spontaneous urticaria (CSU) by year-end, after a trial showed a 50% reduction in itch and urticaria activity scores. The companies also announced positive results in bullous pemphigoid and plan to seek U.S. approval for this indication. Despite challenges, Dupixent is used by 1 million patients across seven indications, with Japan being the first to approve it for CSU.
Sanofi and Regeneron's Dupixent meets success criteria in Phase III study for bullous pemphigoid.
Sanofi's Phase III LIBERTY-CUPID Study C of Dupixent in chronic spontaneous urticaria (CSU) met primary and key secondary endpoints. The study, focusing on biologic-naïve patients with uncontrolled CSU on antihistamines, showed Dupixent reduced itch severity by 8.64 points vs. 6.10 points with placebo at 24 weeks. Additionally, 30% of Dupixent patients reported no urticaria, compared to 18% on placebo. Safety results aligned with Dupixent's known profile, with treatment-emergent adverse events at 53% for both Dupixent and placebo.
Dupixent phase 3 study (LIBERTY-CUPID C) confirms significant improvements in itch and hives for CSU patients, meeting primary and key secondary endpoints with a nearly 50% reduction in itch and urticaria activity scores compared to placebo. Data supports regulatory resubmission in the US by year-end, aiming for Dupixent to become the first targeted therapy for CSU in a decade.
Dupixent Phase 3 trial (LIBERTY-CUPID Study C) met primary and key secondary endpoints for treating uncontrolled, biologic-naïve chronic spontaneous urticaria (CSU) with antihistamines, showing significant reductions in itch and hives. Dupixent-treated patients reported a 50% reduction in itch and urticaria activity scores compared to placebo, with 30% achieving complete response. Safety results were consistent with known profiles, and detailed results will be submitted to the FDA by year-end 2024.