Image source: © 2025 Krish Capital Pty.Ltd

Highlights

  • CHMP recommends approval of Dupixent for chronic spontaneous urticaria in EU patients.
  • Recommendation supported by Phase 3 trials showing reduction in itch and hives at 24 weeks.
  • Final European Commission decision on Dupixent approval expected in coming months.

Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi (NASDAQ: SNY | EURONEXT: SAN) announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending approval of Dupixent® (dupilumab) in the European Union for the treatment of chronic spontaneous urticaria (CSU) in adults and adolescents.

The recommendation covers patients aged 12 years and older with moderate-to-severe CSU who have an inadequate response to histamine-1 antihistamines (H1AH) and are naive to anti-immunoglobulin E (IgE) therapy. A final decision from the European Commission is expected in the coming months.

The opinion is supported by data from the LIBERTY-CUPID Phase 3 program, including Study A and Study C, both of which demonstrated that Dupixent significantly reduced itch and hives at 24 weeks compared to placebo. A third trial, Study B, provided additional safety data in a different CSU patient population.

Safety results in the trials were generally consistent with the known safety profile of Dupixent in its approved indications. The most common adverse events (≥5%) observed in adults and adolescents with CSU included injection site reaction, COVID-19, hypertension, CSU, and accidental overdose.

Dupixent is already approved for CSU in certain adults and adolescents in markets including Japan and the United States. Outside approved jurisdictions, safety and efficacy for this indication remain under regulatory review.

CSU is a chronic, inflammatory skin disease associated with sudden hives and persistent itch. It is typically treated with H1AH, but many patients remain uncontrolled and face limited treatment options.

Dupixent, invented using Regeneron’s VelocImmune® technology, is a fully human monoclonal antibody that inhibits interleukin-4 (IL-4) and interleukin-13 (IL-13) signaling. It is not classified as an immunosuppressant. To date, Dupixent has received regulatory approvals in more than 60 countries across multiple indications, including atopic dermatitis, asthma, eosinophilic esophagitis, prurigo nodularis, chronic rhinosinusitis with nasal polyps, chronic obstructive pulmonary disease, and bullous pemphigoid. More than 1 million patients worldwide are currently being treated with the medicine.

Dupilumab is being jointly developed by Regeneron and Sanofi under a global collaboration agreement and has been studied across more than 60 clinical trials involving over 10,000 patients.