Dupixent is making headlines again with its recent approval in the EU. Sanofi and Regeneron jointly announced that this drug has received EU approval for chronic spontaneous urticaria (CSU), making it the first targeted therapy for this indication in the EU in over a decade.

The data is indeed solid: two Phase III clinical trials showed that Dupixent significantly reduces itching and urticaria activity, with the complete response rate at 24 weeks far exceeding that of the placebo group.

Even more impressive are the sales figures—global sales reached 1.147 billion euros in the first nine months of 2025, a year-on-year increase of 22.7%. Sanofi expects Dupixent to achieve sales of 2.2 billion euros by 2030. Regeneron earned 4.24 billion dollars from its collaboration with Sanofi, a year-on-year increase of 27.8%.

Currently, Dupixent has been approved for 7 inflammatory diseases in the European Union and 8 in the United States. There is also an application for allergic fungal sinusitis under priority review by the FDA, with results expected before February 2026. If approved, this would be the 9th indication for Dupixent in the United States.

From a stock perspective, Sanofi's increase this year is only 1.9%, lagging behind the average growth of 16% in the biopharmaceutical industry. However, this drug clearly has more stories to tell.