Teva Receives FDA Fast Track for Celiac Disease Treatment

Teva Pharmaceutical Industries has received Fast Track designation from the FDA for its investigational drug TEV-53408, an anti-IL-15 monoclonal antibody aimed at treating celiac disease in patients adhering to a gluten-free diet. TEV-53408 is designed to inhibit interleukin-15, a cytokine involved in the immune response that causes intestinal damage in celiac disease, a condition affecting about 1% of the global population. Despite strict dietary restrictions, many patients continue to experience symptoms due to accidental gluten exposure, underscoring the urgent need for new therapeutic options. The drug is currently in a Phase 2a clinical trial assessing its safety and efficacy in adults and reflects Teva's commitment to advancing innovative treatments for autoimmune diseases. The FDA's fast track status is intended to expedite the development and review process, potentially bringing this promising treatment to market sooner. Teva's Chief Medical Officer emphasized the designation as recognition of both the drug's potential and the unmet medical need of people living with celiac disease.