{"id":58446,"date":"2026-02-28T14:22:52","date_gmt":"2026-02-28T06:22:52","guid":{"rendered":"https:\/\/flcube.com\/?p=58446"},"modified":"2026-02-28T14:22:53","modified_gmt":"2026-02-28T06:22:53","slug":"dupixent-wins-chmp-positive-opinion-for-pediatric-csu-eu-approval-nears-for-children-aged-2-11-years","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=58446","title":{"rendered":"Dupixent Wins CHMP Positive Opinion for Pediatric CSU \u2013 EU Approval Nears for Children Aged 2\u201311 Years"},"content":{"rendered":"\n

Sanofi<\/strong> (NASDAQ:\u202fSNY<\/a>) announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP)<\/strong> adopted a positive opinion<\/strong> recommending approval of Dupixent (dupilumab)<\/strong> for chronic spontaneous urticaria (CSU)<\/strong> in children aged 2\u201311 years<\/strong> with moderate\u2011to\u2011severe disease<\/strong>, inadequate response to H1\u2011antihistamines<\/strong>, and na\u00efve to anti\u2011IgE therapy<\/strong>. The recommendation follows prior EU approval for adults and adolescents (\u2265\u202f12 years)<\/strong> and expands Dupixent’s CSU franchise to younger patients. A final EC decision is expected in the coming months<\/strong>, while a US sBLA<\/strong> for the same population is under FDA review with a decision expected by April\u202f2026<\/strong>.<\/p>\n\n\n\n

Regulatory Milestone<\/h2>\n\n\n\n
Item<\/th>Detail<\/th><\/tr><\/thead>
Companies<\/strong><\/td>Sanofi + Regeneron (global collaboration)<\/td><\/tr>
Product<\/strong><\/td>Dupixent (dupilumab)<\/td><\/tr>
Drug Class<\/strong><\/td>Fully human anti\u2011IL\u20114R\u03b1 monoclonal antibody<\/td><\/tr>
Regulatory Body<\/strong><\/td>EMA CHMP (positive opinion); EC (final decision pending)<\/td><\/tr>
New Indication<\/strong><\/td>Chronic spontaneous urticaria (CSU)<\/td><\/tr>
Patient Population<\/strong><\/td>Children aged 2\u201311 years<\/strong><\/td><\/tr>
Treatment History<\/strong><\/td>Inadequate H1\u2011antihistamine response; anti\u2011IgE na\u00efve<\/td><\/tr>
US Status<\/strong><\/td>sBLA accepted; FDA decision expected April\u202f2026<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n

Clinical Evidence \u2013 LIBERTY\u2011CUPID Program<\/h2>\n\n\n\n
Study<\/th>Population<\/th>Design<\/th><\/tr><\/thead>
Study A & Study C<\/strong><\/td>Children aged 6\u201311 years<\/strong><\/td>Phase\u202f3 (NCT04180488)<\/td><\/tr>
CUPIDKids<\/strong><\/td>Children aged 2\u201311 years<\/strong><\/td>Single\u2011arm Phase\u202f3 (NCT05526521)<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n

Dupixent Franchise Overview<\/h2>\n\n\n\n
Parameter<\/th>Detail<\/th><\/tr><\/thead>
Mechanism<\/strong><\/td>Inhibition of IL\u20114 and IL\u201113 signaling pathways<\/td><\/tr>
Global Approvals<\/strong><\/td>60+ countries<\/strong><\/td><\/tr>
Approved Indications<\/strong><\/td>Atopic dermatitis, asthma, CRSwNP, EoE, prurigo nodularis, CSU, COPD, bullous pemphigoid<\/td><\/tr>
CSU Approvals<\/strong><\/td>Adults (EU\/US); Adolescents \u2265\u202f12 years (EU); Pediatric 2\u201311 years (CHMP positive opinion)<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n

Strategic Implications<\/h2>\n\n\n\n