Press Release: Sanofi's Tzield accepted for priority review in the US for young children with stage 2 type 1 diabetes

Core Viewpoint - The FDA has accepted a supplemental biologic license application for Tzield to expand its age indication to children as young as one year old, aiming to delay the onset of stage 3 type 1 diabetes in patients diagnosed with stage 2 T1D [1][2]. Group 1: FDA Review and Study Data - The FDA's priority review highlights the urgent need for innovative therapies like Tzield, which may prevent the progression of T1D by delaying the loss of insulin production [2][3]. - The application is supported by positive interim one-year data from the ongoing PETITE-T1D phase 4 study, which evaluates Tzield's safety and pharmacokinetics in young children [1][4]. - The target action date for the FDA's decision on the application is April 29, 2026 [1]. Group 2: Study Details - The PETITE-T1D study is a phase 4, single-arm, non-randomized, open-label trial designed to assess Tzield's safety and pharmacokinetics in children under eight years diagnosed with stage 2 T1D [4]. - The study has enrolled 23 participants, with a treatment regimen consisting of an intravenous infusion of Tzield once daily for 14 consecutive days, and individual follow-up may last up to 26 months [5]. Group 3: Tzield Overview - Tzield (teplizumab-mzwv) is a CD3-directed monoclonal antibody and the first disease-modifying therapy for autoimmune T1D, initially approved in the US in November 2022 for patients aged eight and older [6]. - Tzield is also approved in several countries, including China, the UK, Canada, and others, for delaying the onset of stage 3 T1D in the same population [6]. - If approved for younger patients, Tzield would be the first therapy to delay the onset of stage 3 T1D in children aged one and older diagnosed with stage 2 T1D [8].