Teva’s Potential Treatment For Celiac Disease Gets Fast Track Designation From US FDA To Speed Up Clinical Review

Teva Pharmaceutical Industries Ltd. announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to TEV-53408, an investigational anti-IL-15 antibody being developed for the treatment of celiac disease in individuals who follow a gluten-free diet. The Fast Track designation is intended to support the development of therapies for serious conditions that have limited treatment options by facilitating a faster and more efficient review process.

TEV-53408 is currently being studied in a Phase 2a clinical trial to evaluate its safety and effectiveness in adults with celiac disease. The drug is designed to block interleukin-15 (IL-15), a cytokine believed to play a key role in causing intestinal damage and symptoms in people with celiac disease. By inhibiting IL-15, TEV-53408 aims to reduce the immune response triggered by gluten exposure, even in those adhering to a gluten-free diet.

Eric Hughes, MD, PhD, Executive Vice President, Global R&D and Chief Medical Officer at Teva, mentioned, “The FDA’s decision to grant Fast Track designation for TEV-53408, an investigational anti-IL-15 antibody therapy, reflects the promising nature of the treatment and the urgent unmet need of people living with celiac disease. Teva is driven by a commitment to innovation and this latest achievement gets us one step closer to providing promising, innovative treatment options for patients with chronic autoimmune diseases like celiac disease.”

The Fast Track status highlights the potential of TEV-53408 to address an important unmet need for people with celiac disease, many of whom continue to experience symptoms despite strict dietary management. This development also underscores Teva’s growing focus on immunological research and innovation, as part of its broader commitment to advancing treatments for chronic and underserved medical conditions.