Dupixent Data Could Scratch A Regulatory Itch

 
• By Elizabeth Cairns
  
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New pivotal data on Regeneron and Sanofi’s antibody in chronic urticaria are underwhelming, though probably sufficient for approval. A green light may beckon in bullous pemphigoid, too.

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Dupixent progresses in chronic urticaria and bullous pemphigoid (Shutterstock)

Sanofi and Regeneron are to take their mega-blockbuster Dupixent back to regulators in chronic itching by the end of the year after hitting the primary endpoint in a third Phase III trial in the disease. This could lead to the US Food and Drug Administration reversing its earlier decision to reject the drug – but the data do not look hugely competitive with other agents in this space.

Key Takeaways

  • A third Phase III trial of Sanofi and Regeneron’s IL-4/IL-13 inhibitor Dupixent in chronic spontaneous urticaria has succeeded, potentially allowing US approval of the antibody at the second time of asking. 

The partners also scored a victory with the IL-4/IL-13 inhibitor in the smaller indication of bullous pemphigoid, potentially allowing Dupixent...

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