European Commission Approves Dupixent as First-Line Targeted Therapy for Chronic Spontaneous Urticaria
Key Insights
The European Commission has approved Dupixent (dupilumab) as the first targeted therapy for chronic spontaneous urticaria (search) in Europe in more than a decade.
The approval covers adults and adolescents aged 12 and older with moderate-to-severe CSU (search) who have inadequate response to histamine-1 antihistamines (search) and are naive to anti-IgE therapy.
Dupixent is now approved for patients across seven chronic, inflammatory diseases in the EU, with global net sales exceeding $14 billion last year.
Regeneron Pharmaceuticals and Sanofi have secured European Commission approval for their blockbuster anti-inflammatory drug Dupixent (dupilumab) as a first-line targeted treatment for chronic spontaneous urticaria (search) (CSU (search)), marking a significant milestone for patients with this debilitating skin condition.
The approval covers Dupixent for adults and adolescents aged 12 and older with moderate-to-severe CSU (search) who have an inadequate response to histamine-1 antihistamines (search) and who are naive to anti-immunoglobulin E (search) therapy for CSU. This represents the first targeted therapy approved in Europe for CSU in more than a decade.
Addressing Unmet Medical Need
Chronic spontaneous urticaria (search) is a chronic, inflammatory skin disease driven in part by type 2 inflammation, which causes sudden and debilitating hives and recurring itch. The condition is typically treated with histamine-1 antihistamines (search), medicines that target H1 receptors (search) on cells to control symptoms of itch and urticaria. However, the disease remains uncontrolled despite H1AH treatment in many patients, some of whom are left with limited alternative treatment options. These individuals continue to experience symptoms that can be debilitating and significantly impact their quality of life.
Expanding Therapeutic Portfolio
With this latest approval, Dupixent is now approved for patients across seven chronic, inflammatory diseases in the EU. The drug is also approved for chronic spontaneous urticaria (search) in certain adults and adolescents in several countries including the US and Japan.
Commercial Impact
The Tarrytown, N.Y.-based biotechnology company Regeneron created Dupixent and markets it jointly in the U.S. with France's Sanofi under a 2007 collaboration agreement, while Sanofi markets the drug internationally. Dupixent achieved global net sales exceeding $14 billion last year, underscoring its commercial success across multiple indications.
Following the announcement, Regeneron shares traded up 2.4% to $779.71 while Sanofi American Depositary Receipts increased 1.7% to $49.97, reflecting investor confidence in the expanded therapeutic potential of this blockbuster drug.