Dupixent has obtained approval for a new indication in the EU, another blockbuster drug is on the way.

Sanofi and Regeneron jointly announced that Dupixent has been approved by the European Union for the treatment of moderate to severe chronic spontaneous urticaria in patients aged 12 and older. This is the first targeted therapy for this condition in the EU in over a decade.

Data from the LIBERTY-CUPID Phase 3 clinical trial: At 24 weeks, patients in the Dupixent group showed significant improvement in itch and urticaria activity, with a complete response rate significantly higher than that of the placebo group. The safety profile is consistent with existing indications.

The more critical aspect is the sales potential—Dupixent has become a cash cow for both companies:
✦ Global sales reached 11.47 billion euros in the first 9 months before 2025, a year-on-year increase of 22.7%.
✦ Sanofi expects sales to reach 22 billion euros by 2030.
✦ Regeneron generated $4.24 billion in revenue from collaborations, a year-on-year increase of 27.8%.

Currently, this drug has been approved for 8 indications globally, with more under review. For these two stocks, each expansion of Dupixent signifies growth potential.