Teva Pharmaceutical Industries Limited (TEVA) Wins FDA Fast Track for Celiac Disease Drug TEV-53408

Teva Pharmaceutical Industries Limited (NYSE:TEVA) announced today that its investigational drug TEV-53408 has received Fast Track designation from the US Food and Drug Administration (FDA) for the treatment of celiac disease in patients adhering to a gluten-free diet. TEV-53408 is an anti-IL-15 monoclonal antibody designed to inhibit interleukin-15, a cytokine implicated in the immune response that leads to intestinal damage in celiac disease. The drug is currently being evaluated in a Phase 2a clinical trial to assess its efficacy and safety in adults with the condition.

Teva Pharmaceutical Industries Limited (NYSE:TEVA) Wins FDA Fast Track for Celiac Disease Drug TEV-53408

A scientist in a laboratory working on a gene editing tool, to create treatments for rare genetic diseases.

The FDA’s Fast Track process is intended to accelerate the development and review of drugs that address serious conditions and unmet medical needs. Celiac disease, an autoimmune disorder triggered by gluten, affects about 1% of the global population. Despite strict adherence to a gluten-free diet, the only current treatment many patients continue to experience debilitating symptoms due to accidental gluten exposure.

Teva Pharmaceutical Industries Limited (NYSE:TEVA)’s Executive Vice President and Chief Medical Officer, Dr. Eric Hughes, highlighted that this designation reflects both the promise of TEV-53408 and the urgent need for new therapeutic options. The development of TEV-53408 underscores Teva Pharmaceutical Industries Limited (NYSE:TEVA)’s commitment to advancing innovative treatments for chronic autoimmune diseases like celiac disease.

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