Sanofi Secures Dual EU Approvals: Dupixent for Chronic Urticaria and First-Ever BTK Inhibitor Wayrilz for Immune Thrombocytopenia
Key Insights
Sanofi received European Commission approval for Dupixent as the first targeted medicine in over a decade for moderate-to-severe chronic spontaneous urticaria (search), benefiting an estimated 270,000 EU patients.
The company also gained first-ever EU approval for BTK (search) inhibitor Wayrilz for adult immune thrombocytopenia (search) patients refractory to other treatments, expanding its rare disease portfolio.
Both approvals strengthen Sanofi's position in immunology and rare diseases, with Wayrilz supported by positive phase 3 LUNA 3 data showing rapid platelet responses and quality-of-life improvements.
Sanofi and Regeneron have achieved significant regulatory milestones in Europe with two groundbreaking approvals that expand treatment options for patients with challenging immune-mediated conditions. The European Commission granted approval for Dupixent (dupilumab) as the first targeted medicine in over a decade for treating moderate-to-severe chronic spontaneous urticaria (search) (CSU) in the EU, while separately approving Wayrilz (rilzabrutinib) as the first Bruton's tyrosine kinase (search) (BTK (search)) inhibitor for adult immune thrombocytopenia (search) (ITP) patients.
Dupixent Breakthrough in Chronic Urticaria
The November 25, 2025 approval of Dupixent represents a major advancement for patients with CSU, a condition affecting an estimated 270,000 individuals in the EU. Based on phase 3 studies, the approval provides a new treatment option that significantly reduces symptoms like itch and hives, which were previously inadequately controlled by standard antihistamines.
This approval marks the first targeted therapy for CSU in over a decade, addressing a significant unmet medical need in patients whose symptoms remain poorly controlled despite conventional treatment approaches. The regulatory decision is expected to enhance Sanofi's position in the immunology market while offering hope to patients struggling with this chronic condition.
First-in-Class BTK Inhibitor Approval
On December 23, 2025, the European Commission approved Wayrilz as the first BTK (search) inhibitor indicated for adult ITP patients who are refractory to other treatments. This once-daily oral therapy, already approved in the US and UAE, represents a significant expansion of Sanofi's rare disease portfolio in a complex, underserved patient segment.
The approval is supported by positive phase 3 LUNA 3 data demonstrating rapid, durable platelet responses and quality-of-life improvements versus placebo. This regulatory success strengthens Sanofi's positioning in immunology and rare diseases while underscoring the strategic value of its BTK (search) and TAILORED COVALENCY® platform.
Strategic Portfolio Expansion
Both approvals reflect Sanofi's commitment to addressing unmet medical needs in immunology and rare diseases. The company's success with these targeted therapies demonstrates the potential of its research and development capabilities in developing innovative treatments for complex conditions.
Sanofi continues to investigate additional rare indications that could further broaden its specialty care franchise, leveraging its expertise in immunology and proprietary technologies. The company's focus on rare and inflammatory diseases, immune-mediated conditions, and broader public health needs positions it as a leader in developing medicines for underserved patient populations.
These regulatory victories come as Sanofi maintains its position as an R&D-driven, AI-powered biopharmaceutical company listed on Euronext Paris and Nasdaq, with deep expertise in immunology and an innovative pipeline aimed at improving outcomes for millions of patients worldwide.