Home PharmTech FDA Grants Fast Track Designation to Teva Celiac Disease Candidate

FDA Grants Fast Track Designation to Teva Celiac Disease Candidate

by Newsroom


Teva Pharmaceuticals manufacturing site. Locally, Teva produces oral solid medicines and packaging. | Image Credit: © jetcityimage – stock.adobe.com

Teva Pharmaceutical Industries announced on May 27, 2025 that its investigational anti-interleukin-15 (IL-15) antibody, TEV-53408, has been granted Fast Track status by FDA (1). The treatment is intended for people with celiac disease who are on a gluten-free diet.

Such a diet—which must be kept strictly and lifelong—is currently the only treatment for celiac disease, a chronic, autoimmune disorder that is triggered by gluten and results in a range of mostly gastrointestinal symptoms (1). TEV-53408…



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