Sanofi and Regeneron have announced that the European Medicines Agency (EMA)’s Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending the approval of Dupixent (dupilumab) in the EU for the treatment of chronic spontaneous urticaria (CSU) in adults and adolescents.

CSU is a chronic, inflammatory skin disease driven in part by type 2 inflammation, which causes sudden and debilitating hives and recurring itch. CSU is typically treated with histamine-1 antihistamines (H1AH), medicines that target H1 receptors on cells to control symptoms of itch and urticaria. However, the disease remains uncontrolled despite H1AH treatment in many patients.

The CHMP recommendation covers those aged 12 years and above with moderate to severe disease, with inadequate response to H1AH, and who are naive to anti-immunoglobulin E (IgE) therapy. It is based on phase 3 studies that demonstrated Dupixent significantly reduced itch and hives at 24 weeks compared to placebo. A final decision is expected in the coming months.     

If approved, Dupixent would be the first targeted medicine in over a decade indicated for CSU in the EU.

Jointly developed by Sanofi and Regeneron under a global collaboration agreement, dupilumab has been studied in more than 60 clinical studies involving over 10,000 patients with various chronic diseases, driven in part by type 2 inflammation.

The drug has received regulatory approvals in more than 60 countries in one or more indications, including certain patients with atopic dermatitis, asthma, chronic rhinosinusitis with nasal polyps, eosinophilic esophagitis, prurigo nodularis, CSU, chronic obstructive pulmonary disease, and bullous pemphigoid in different age populations. 

Dupixent is approved for CSU in certain adults and adolescents in several countries, including Japan and the US. Outside of approved jurisdictions, the safety and efficacy of Dupixent for CSU has not been fully evaluated by any regulatory authority.

Sanofi and Regeneron are also studying dupilumab in many other diseases driven by type 2 inflammation or other allergic processes in phase 3 studies, including chronic pruritus of unknown origin and lichen simplex chronicus. These potential uses of dupilumab are currently under clinical investigation.