Globenewswire·2025-10-20 11:30Core Insights - The FDA has accepted Sanofi's Tzield for expedited review to delay the progression of stage 3 type 1 diabetes (T1D) in patients aged eight and older [1][2] - Tzield has been nominated for the Commissioner's National Priority Voucher pilot program due to its potential to address significant unmet medical needs [1][2] - The supplemental biologics license application (sBLA) is supported by the PROTECT phase 3 study, which demonstrated significant preservation of beta cell function [2][8] Regulatory and Clinical Development - Tzield is currently under expedited review and also being evaluated under the accelerated approval program, which allows for review based on surrogate endpoints [4][9] - The PROTECT phase 3 study involved 328 participants and aimed to assess the preservation of beta cell function through C-peptide levels [7][8] - If approved, Tzield would be the first disease-modifying therapy for stage 3 T1D [9] Safety and Efficacy - Adverse events in the PROTECT study were consistent with previous studies, with common events including headache, nausea, and gastrointestinal symptoms [3] - 1.8% of participants receiving Tzield developed cytokine release syndrome possibly related to the treatment [3] - The safety and efficacy of Tzield in stage 3 T1D have not yet been approved by any regulatory authority [6] Market Position and Approval Status - Tzield is already approved in multiple countries, including the US, UK, China, and Canada, for delaying the onset of stage 3 T1D in patients diagnosed with stage 2 T1D [5][12] - Regulatory reviews for Tzield are ongoing in the EU and other jurisdictions [5]