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Communiqué de presse : Le Tzield de Sanofi approuvé aux États-Unis comme première thérapie modificatrice de la maladie pour les patients récemment diagnostiqués avec un diabète de type 1 au stade 3
GlobeNewswire Inc.·
The FDA granted accelerated approval to Sanofi's Tzield (teplizumab-mzwv) for children aged 8-17 recently diagnosed with stage 3 type 1 diabetes, marking the first disease-modifying therapy for this indication. The approval is based on the phase 3 PROTECT trial demonstrating significant slowing of C-peptide decline. A confirmatory phase 3 BETA-PRESERVE study is currently underway.
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