Dupixent's European Approval Signals Strong Growth Trajectory for Sanofi & Regeneron

Global Sales Momentum Behind the Latest Regulatory Green Light

The pharmaceutical world just witnessed another significant milestone: Dupixent (dupilumab), co-developed by Sanofi and Regeneron, has officially received the European Commission’s regulatory nod for treating moderate-to-severe chronic spontaneous urticaria (CSU) in adults and adolescents aged 12 and above. This designation is particularly notable as it marks the first targeted therapy approved for CSU in the EU within the past decade—a meaningful achievement in a treatment category historically dominated by conventional antihistamines.

What makes this development especially compelling for investors is the financial trajectory backing it. During the first nine months of 2025, Dupixent generated €11.47 billion in global sales, representing an impressive 22.7% year-over-year growth rate. Sanofi records these sales figures directly, while Regeneron captures collaboration revenues of $4.24 billion from the same period, reflecting a robust 27.8% increase. Looking ahead, Sanofi has set an ambitious target: projecting Dupixent to hit approximately €22 billion in annual sales by 2030.

Clinical Validation Paving the Way for Expanded Use Cases

The European Commission’s decision rests on substantial clinical evidence. Two pivotal phase III studies from the LIBERTY-CUPID program demonstrated that Dupixent, when added to standard antihistamine therapy, significantly outperformed placebo at the 24-week mark. Patients receiving the treatment experienced meaningful reductions in itching and hive activity, with a notably higher percentage achieving well-controlled disease status and complete response compared to the control group.

Importantly, the safety profile observed across all three studies in the program remained consistent with what has been documented in Dupixent’s previously approved indications. This consistency strengthens physician confidence in prescribing the drug for this emerging indication.

Expanding the Portfolio Beyond CSU

CSU represents just the latest addition to Dupixent’s growing list of approved indications. In the United States alone, the therapy now carries approval for eight type II inflammatory conditions—including severe asthma, moderate-to-severe atopic dermatitis, eosinophilic esophagitis, and prurigo nodolaris, among others. The April 2025 FDA approval for CSU marked Dupixent’s seventh U.S. indication, followed by an eighth approval in June 2025 for bullous pemphigoid. Within the European Union, Dupixent is now approved across seven distinct chronic inflammatory conditions.

The pipeline shows no signs of slowing. Currently under FDA priority review is a supplemental application seeking approval for allergic fungal rhinosinusitis (AFRS) in patients six years and older—a decision expected by February 28, 2026. If approved, this would represent Dupixent’s ninth indication in the U.S. market.

Understanding the Disease and Treatment Landscape

Chronic spontaneous urticaria is fundamentally a type II inflammatory condition characterized by sudden-onset hives and swelling that remain inadequately managed through conventional antihistamine monotherapy. For patients who fail to respond sufficiently to histamine-1 receptor antagonists and have not previously received anti-IgE treatment, this new option addresses a significant therapeutic gap.

Strategic Commercial Alignment

The joint marketing arrangement between Sanofi and Regeneron underscores the collaborative nature of modern pharmaceutical development. Sanofi handles global net sales reporting, while Regeneron participates through profit-sharing mechanisms aligned with worldwide commercial performance. This structure has already proven highly lucrative for both parties, with financial results demonstrating consistent double-digit growth rates.

What’s Next for the Sector

As Dupixent continues its global expansion across multiple indications and geographies, the approval trajectory reinforces the market’s confidence in its therapeutic utility. The consistent safety data, coupled with strong commercial momentum, positions this treatment as a cornerstone therapy in the type II inflammatory disease space for years to come.