Dupixent, Regeneron and FDA
Regeneron, Sanofi Get New FDA Review of Dupixent for CSU
The FDA last year turned away the companies' application and asked for additional efficacy data. Regeneron and Sanofi said the resubmission adds results from an additional Phase 3 study of Dupixent in CSU, which causes sudden and debilitating hives and recurring itch.
The FDA has provided a date of April 18, 2025, to review the application for Dupixent to treat patients with chronic ...
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Regeneron And Sanofi Snag Their $6 Billion-Potential COPD Approval For DupixentRegeneron announced Friday that the company won Food and Drug Administration approval for Dupixent in chronic obstructive .
Resubmission includes new pivotal data which confirm Dupixent significantly reduced itch and hive activityMore than 300,000 people in the U.S.
Eli Lilly’s Ebglyss (lebrikizumab-lbkz) showed improvement in skin clearance and itch relief for most patients with ...
The BOREAS Phase III trial showed DUPIXENT reduced exacerbations by 30% and improved lung function by 160 mL at 52 weeks.
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