Press Release: Sanofi's Tzield accepted for expedited review in the US for stage 3 type 1 diabetes through FDA Commissioner's National Priority Voucher pilot program

Core Viewpoint - The FDA has accepted Sanofi's Tzield for expedited review to delay the progression of stage 3 type 1 diabetes, highlighting its potential to address a significant unmet medical need [1][2]. Regulatory Review - Tzield's supplemental biologics license application (sBLA) is part of the Commissioner's National Priority Voucher pilot program, which aims to reduce the review time from 10-12 months to 1-2 months while ensuring safety and efficacy standards [1]. - Tzield is also under review for accelerated approval, which allows the FDA to evaluate therapies for serious conditions based on surrogate endpoints [4][9]. Clinical Study Results - The sBLA is supported by the PROTECT phase 3 study, which demonstrated significant preservation of beta cell function by slowing the decrease in mean C-peptide levels compared to placebo [2][8]. - The PROTECT study involved 328 participants aged 8-17 years, with a randomization ratio of 2:1 for Tzield versus placebo [7]. Safety Profile - Adverse events in the PROTECT study were consistent with previous studies, with common events including headache, nausea, and gastrointestinal symptoms. 1.8% of participants developed cytokine release syndrome possibly related to Tzield [3]. Market Position - If approved, Tzield would be the first disease-modifying therapy for stage 3 type 1 diabetes in adults and pediatric patients aged eight years and older [9]. - Tzield is already approved in multiple countries, including the US, UK, China, and Canada, for delaying the onset of stage 3 type 1 diabetes in patients diagnosed with stage 2 [5][12]. Company Overview - Sanofi is an R&D-driven biopharma company focused on improving lives through innovative medicines and vaccines, with a commitment to addressing urgent healthcare challenges [13].