Teva Celiac Disease Candidate Granted Fast Track Designation by US FDA

Rhea-AI Summary

Teva Pharmaceutical (NYSE: TEVA) has received Fast Track designation from the FDA for TEV-53408, an anti-IL-15 antibody being developed for celiac disease treatment. The drug candidate is currently in Phase 2a trials evaluating its efficacy and safety in adult celiac patients on a gluten-free diet. TEV-53408 works by inhibiting interleukin-15 (IL-15) to prevent intestinal damage and associated symptoms. The Fast Track status highlights the treatment's potential and the significant unmet medical need in celiac disease, which affects approximately 1% of the global population. This development demonstrates Teva's commitment to expanding its innovative pipeline in immunological conditions.

Positive

• FDA Fast Track designation received, potentially expediting development and review process
• Addresses an unmet medical need in celiac disease affecting 1% of global population
• Demonstrates progress in Teva's innovative pipeline for immunological conditions

Negative

• Drug still in early Phase 2a trials with no efficacy data reported yet
• Success in clinical trials and eventual FDA approval not guaranteed

Insights

Biotechnology Research Analyst

FDA Fast Track designation for Teva's celiac disease drug TEV-53408 accelerates development timeline, addressing significant unmet medical need in a global market.

The FDA's Fast Track designation for Teva's investigational anti-IL-15 antibody TEV-53408 represents a significant regulatory milestone in the celiac disease treatment landscape. This designation specifically acknowledges two critical factors: the serious nature of celiac disease and the substantial unmet medical need that exists despite gluten-free diets.

The Fast Track program offers Teva several tangible advantages that investors should understand:

• More frequent FDA communication to optimize drug development
• Eligibility for Accelerated Approval and Priority Review if criteria are met
• Rolling Review allowing sequential submission of completed sections of the application

From a mechanism perspective, TEV-53408's targeting of IL-15 is scientifically sound. IL-15 is a critical cytokine that drives the intestinal damage in celiac disease by activating intraepithelial lymphocytes. By neutralizing IL-15, TEV-53408 aims to prevent the immune-mediated intestinal damage that persists in many patients despite adherence to gluten-free diets.

The global celiac disease market represents a substantial opportunity, affecting approximately 1% of the global population (roughly 80 million people). Currently, no FDA-approved pharmacological treatments exist - the standard remains a strict gluten-free diet, which is difficult to maintain and often insufficient for complete symptom resolution.

While this Phase 2a study is still evaluating efficacy, the Fast Track designation positions Teva to potentially capture first-mover advantage in this underserved market. The designation also validates Teva's strategic pivot toward innovative specialty medicines beyond their traditional generics business, potentially improving their competitive positioning and profit margins long-term.

• Fast Track designation granted for investigational TEV-53408, an anti-IL-15 antibody
• Designation underscores the potential of TEV-53408, currently undergoing a Phase 2a study for the treatment of celiac disease
• Candidate demonstrates Teva’s commitment to bringing important new treatment options to underserved patient populations
  

TEL AVIV, Israel, May 27, 2025 (GLOBE NEWSWIRE) -- Teva Pharmaceutical Industries, Ltd. (NYSE and TASE: TEVA) today announced that the US Food and Drug Administration (FDA) granted Fast Track designation for investigational TEV-53408, an anti-IL-15 antibody, for the treatment of people with celiac disease on a gluten-free diet. TEV-53408 is currently being evaluated in a Phase 2a trial to assess the efficacy and safety in adults with celiac disease.

Fast Track is an FDA process designed to facilitate development and expedite review of drugs to treat serious conditions and address unmet medical needs.

“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,” said Eric Hughes, MD, PhD, Executive Vice President, Global R&D and Chief Medical Officer at Teva. “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.”

TEV-53408 is an antibody designed to inhibit the activity of the cytokine, interleukin-15 (IL-15), to prevent intestinal damage and associated symptoms in individuals with celiac disease. This potential treatment is a testament to the growing strength of Teva’s innovative pipeline and dedication to advancing treatments for immunological conditions, including celiac disease, which affects approximately 1% of the global population.^1-3

About TEV-53408

TEV-53408 is an investigational monoclonal antibody that inhibits interleukin-15 (IL-15), which aims to reduce the immune response to gluten that causes intestinal inflammation and damage in individuals with celiac disease. A Phase 2a study investigating the efficacy and safety of anti-IL-15 in adults with celiac disease is ongoing (NCT06807463).

About Celiac Disease

Celiac disease is a chronic autoimmune disorder triggered by gluten, affecting the small intestine and leading to a range of symptoms. It can significantly impact an individual's quality of life, and diagnosis can be challenging. A strict, lifelong gluten-free diet is the only current treatment and even if adhering to a gluten-free diet, a significant proportion of patients still experience debilitating symptoms. In addition, trace amounts of gluten - especially through accidental or inadvertent ingestion - can cause severe reactions. Teva is dedicated to developing innovative medicines for immunological diseases, including celiac disease, with the goal of providing better health for people suffering from celiac disease worldwide.

About Teva

Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) is a different kind of global biopharmaceutical leader, one that operates across the full spectrum of innovation to reliably deliver medicines to patients worldwide. For over 120 years, Teva’s commitment to bettering health has never wavered. Today, the company’s global network of capabilities enables its 37,000 employees across 57 markets to advance health by developing medicines for the future while championing the production of generics and biologics. We are dedicated to addressing patients’ needs, now and in the future. Moving forward together with science that treats, inspired by the people we serve. To learn more about how Teva is all in for better health, visit www.tevapharm.com.

Cautionary Note Regarding Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, which are based on management’s current beliefs and expectations and are subject to substantial risks and uncertainties, both known and unknown, that could cause our future results, performance or achievements to differ significantly from that expressed or implied by such forward-looking statements. You can identify these forward-looking statements by the use of words such as “should,” “expect,” “anticipate,” “estimate,” “target,” “may,” “project,” “guidance,” “intend,” “plan,” “believe” and other words and terms of similar meaning and expression in connection with any discussion of future operating or financial performance. Important factors that could cause or contribute to such differences include risks relating to: our ability to successfully compete in the marketplace, including our ability to achieve expected results from investments in our product pipeline including to successfully develop and commercialize our anti-IL 15 (TEV-53408) asset for the treatment of people with celiac disease on a gluten-free diet; the risk that we will incur significant costs in connection with the development of anti-IL 15 (TEV-53408), which may exceed any revenue generated by anti-IL 15 (TEV-53408); risks that regulatory approvals and other requirements may delay the development and commercialization of our anti-IL 15 (TEV-53408); our ability to successfully execute our Pivot to Growth strategy, including to expand our innovative and biosimilar medicines pipeline and profitably commercialize the innovative medicines and biosimilar portfolio, whether organically or through business development, to sustain and focus our portfolio of generic medicines, and to execute on our organizational transformation and to achieve expected cost savings; and other factors discussed in our Quarterly Report on Form 10-Q for the first quarter of 2025 and in our Annual Report on Form 10-K for the year ended December 31, 2024, including in the section captioned “Risk Factors and “Forward Looking Statements.” Forward-looking statements speak only as of the date on which they are made, and we assume no obligation to update or revise any forward-looking statements or other information contained herein, whether as a result of new information, future events or otherwise. You are cautioned not to put undue reliance on these forward-looking statements.

References

1. Gatti S, Rubio-Tapia A, Makharia G, Catassi C. Patient and Community Health Global Burden in a World with More Celiac Disease. Gastroenterology. 2024;167(1):23-33.
2. Singh, Prashant et al. Global Prevalence of Celiac Disease: Systematic Review and Meta-analysis. Clinical Gastroenterology and Hepatology, 2018; 16(6), 823 - 836.e2
3. Mustalahti, K., Catassi, C., Reunanen, A., Fabiani, E., Heier, M., … McMillan, S. (2010). The prevalence of celiac disease in Europe: Results of a centralized, international mass screening project. Annals of Medicine, 2010; 42(8), 587–595.

Teva Media Inquiries
TevaCommunicationsNorthAmerica@tevapharm.com

Teva Investor Relations Inquires

TevaIR@Tevapharm.com

FAQ

What is the significance of FDA Fast Track designation for Teva's TEV-53408?

The Fast Track designation will facilitate development and expedite FDA review of TEV-53408, potentially accelerating its path to market for celiac disease treatment.

How does Teva's TEV-53408 work in treating celiac disease?

TEV-53408 is an antibody that inhibits interleukin-15 (IL-15) activity to prevent intestinal damage and associated symptoms in celiac disease patients.

What phase of clinical trials is TEVA's celiac disease treatment currently in?

TEV-53408 is currently in Phase 2a clinical trials, evaluating its efficacy and safety in adults with celiac disease.

How many people could potentially benefit from Teva's celiac disease treatment?

The treatment could potentially benefit approximately 1% of the global population who are affected by celiac disease.

Who is leading the development of TEV-53408 at Teva Pharmaceuticals?

Dr. Eric Hughes, Executive Vice President, Global R&D and Chief Medical Officer at Teva, is overseeing the development of TEV-53408.