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Sanofi (SAN FP) Winthrop Industrie withdrew its application for use of Dupixent on 24th June 2026, according to the EMA

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Sanofi withdrew its EU Dupixent BP application due to data sufficiency disagreements with the EMA, though global sales targets and other approvals remain robust.

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Sanofi Winthrop Industrie withdrew its application for the use of Dupixent in the treatment of adults with moderate-to-severe bullous pemphigoid, an autoimmune skin disease causing widespread itching and blisters affecting the skin and sometimes the inside of the mouth. "The Applicant reluctantly withdraws this application following divergence with the CHMP on the data sufficiency to support the extension of Dupixent indication in the European Union (EU) for the treatment of bullous pemphigoid, a disease with urgent and substantial unmet medical need for which current standard of care (oral corticosteroids) is associated with significant adverse effects. "

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