{"id":63070,"date":"2026-04-14T14:05:32","date_gmt":"2026-04-14T06:05:32","guid":{"rendered":"https:\/\/flcube.com\/?p=63070"},"modified":"2026-04-14T14:05:34","modified_gmt":"2026-04-14T06:05:34","slug":"sanofi-secures-ec-approval-for-dupixent-in-pediatric-chronic-spontaneous-urticaria-first-biologic-therapy-for-children-2-11-years","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=63070","title":{"rendered":"Sanofi Secures EC Approval for Dupixent in Pediatric Chronic Spontaneous Urticaria \u2013 First Biologic Therapy for Children 2\u201311 Years"},"content":{"rendered":"\n

Sanofi SA<\/strong> (NASDAQ: SNY<\/a>) announced that the European Commission (EC)<\/strong> has granted marketing authorization for Dupixent (dupilumab)<\/strong> to treat children aged 2 to 11 years<\/strong> with mild-to-moderate or severe chronic spontaneous urticaria (CSU)<\/strong> who have had an inadequate response to H1 antihistamines and have not received prior anti-immunoglobulin E (IgE) therapy.<\/p>\n\n\n\n

Regulatory Milestone<\/h2>\n\n\n\n
Item<\/th>Detail<\/th><\/tr><\/thead>
Agency<\/strong><\/td>European Commission (EC)<\/td><\/tr>
Approval Type<\/strong><\/td>Full marketing authorization<\/td><\/tr>
Product<\/strong><\/td>Dupixent (dupilumab) \u2013 monoclonal antibody<\/td><\/tr>
Indication<\/strong><\/td>Treatment of CSU in children 2\u201311 years with inadequate response to H1 antihistamines<\/td><\/tr>
Approval Date<\/strong><\/td>14 Apr 2026<\/td><\/tr>
Next Steps<\/strong><\/td>Commercial launch across EU member states within Q2 2026<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n

Drug Profile & Mechanism of Action<\/h2>\n\n\n\n