US EditionTeva Celiac Disease Candidate Granted Fast Track Designation by US FDA
- On May 27, 2025, Teva Pharmaceutical Industries revealed that the FDA has granted a Fast Track status to TEV-53408, a novel antibody targeting IL-15, which is being studied as a potential treatment for adults with celiac disease who maintain a gluten-free diet.
- This recognition comes as TEV-53408 advances through a Phase 2a clinical trial assessing its safety and effectiveness in mitigating the immune-mediated intestinal injury caused by gluten in individuals living with celiac disease.
- Celiac disease affects about 1% of the global population, with current management restricted to a lifelong gluten-free diet that often fails to fully resolve symptoms or prevent intestinal inflammation and villous atrophy.
- Eric Hughes, Teva’s Chief Medical Officer, said the FDA's decision reflects both the promising nature of TEV-53408 and the urgent unmet needs of people living with celiac disease.
- The Fast Track status may accelerate the development and review of TEV-53408, enhancing Teva's strategic focus on innovative treatments for immunological diseases and potentially addressing a significant unmet medical need.
14 Articles
14 Articles
Hastings Tribune
Teva Celiac Disease Candidate Granted Fast Track Designation by US FDA
Fast Track designation granted for investigational TEV-53408, an anti-IL-15 antibodyDesignation underscores the potential of TEV-53408, currently undergoing a Phase 2a study for the treatment of celiac diseaseCandidate demonstrates Teva’s commitment to bringing important new treatment options to underserved patient populations
On the occasion of World Celiac Disease Day, which was on May 16, the Hellenic Celiac Disease Society is organizing today at the Kalokerinou Foundations Social Space in Heraklion, Crete, an open information event. Celiac disease, although it is quite widespread, that is, it affects at least 1% of the population, is unknown to many. The director of the gastroenterology clinic at Venizelio Hospital, Ms. Angeliki Theodoropoulou, on the occasion of …
The month of May is dedicated to raising international awareness about celiac disease. Anna Gunndís Guðmundsdóttir, chairwoman of the Icelandic Celiac Association, says there is still a lot of misunderstanding about the disease.
Coverage Details
Bias Distribution
- 67% of the sources lean Left
Factuality
To view factuality data please Upgrade to Premium
