Regeneron Pharmaceuticals, Inc. (REGN) and Sanofi announced that the European Commission or EC has approved Dupixent or Dupilumab for the treatment of moderate-to-severe chronic spontaneous urticaria (CSU) in children aged 2 to 11 years with an inadequate response to histamine-1 antihistamines and who are naïve to anti-immunoglobulin E therapy for CSU.
Dupixent (Dupilumab) is being jointly developed by Regeneron and Sanofi under a global collaboration agreement and was invented using Regeneron's proprietary VelocImmune technology. It is a fully human monoclonal antibody and is not an immunosuppressant. On November 25, 2025, the EC approved Dupixent for the treatment of moderate-to-severe CSU in adult and adolescent patients 12 years and above. The latest approval expands Dupixent's CSU indication in the EU to include children as young as 2 years.
CSU is a chronic, inflammatory skin disease driven in part by type 2 inflammation, which causes sudden and debilitating hives and recurring itch.
The approval was based on data from the LIBERTY-CUPID clinical trial program, which showed that Dupixent significantly reduced urticaria activity compared with placebo in adults.
The LIBERTY-CUPID Phase 3 program evaluated Dupixent for CSU in children aged 2 to 11 years, including Study A, Study C and CUPIDKids. CUPIDKids was a single-arm clinical trial that assessed the safety, efficacy, and pharmacokinetics of Dupixent in children aged 2 to 11 years with CSU who remained symptomatic despite antihistamine treatment.
Dupixent is a subcutaneous injection administered at different injection sites. In children aged 2 to 11 years with CSU who remain symptomatic despite H1AH treatment, Dupixent is administered based on age and weight.
Dupixent has received regulatory approvals in more than 60 countries for 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, bullous pemphigoid, and allergic fungal rhinosinusitis across different age groups.
In the U.S., the supplemental Biologics License Application for Dupixent has been accepted for review in certain children aged 2 to 11 years with CSU.
Sanofi recorded full-year 2025 Dupixent global net sales of $17.8 billion, from approximately $14.3 billion in the year-ago period.
SNY closed Friday's trade at $46.76, down 0.68%.In the pre-market, SNY is down 0.97% at $46.31.
REGN has traded between $476.49 and $821.11 over the last year. The stock closed Friday's trade at $748.87, down 2.47%.
REGN is currently trading 0.25% down at $747 in the pre-market trading.
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