FDA Grants Fast Track Designation to Drug Candidate for Celiac Disease

Author(s):

Kennedy Ferruggia, Assistant Editor

Key Takeaways

TEV-53408, an anti-IL-15 antibody, received FDA fast track designation for celiac disease treatment, highlighting its potential and unmet medical need.
The ongoing phase 2a study aims to assess TEV-53408's efficacy in reducing gluten-induced enteropathy in celiac patients.
Celiac disease is an autoimmune disorder triggered by gluten, causing intestinal damage and various symptoms, with no current cure.
Pharmacists are vital in managing celiac disease by ensuring gluten-free medications and providing patient education and counseling.

The FDA grants fast track designation to TEV-53408, a promising treatment for celiac disease designed to address gluten intolerance and improve patient outcomes.

The FDA has granted fast track designation to TEV-53408 (Teva Pharmaceutical Industries, Ltd), an investigational anti-IL-15 antibody designed for the treatment of individuals with celiac disease on a gluten-free diet, according to a news release from Teva Pharmaceuticals.¹

Woman can't eat bread and grain products because of gluten intolerance. A young celiac woman suffers from abdominal pain after eating fresh bread - Image credit: weyo | stock.adobe.com

Image credit: weyo | stock.adobe.com

“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,” Eric Hughes, MD, PhD, executive vice president of Global R&D and chief medical officer at Teva Pharmaceuticals, said in the news release.¹

A phase 2a study (NCT06807463) is currently ongoing, investigating the efficacy and safety of anti-IL-15 treatments such as TEV-53408, which acts as an investigational monoclonal antibody that inhibits interleukin-15 (IL-15).¹ The primary efficacy objective of the study is to assess the drugs’ ability to reduce gluten-induced enteropathy among individuals with celiac disease. While the trial is ongoing, researchers expect a duration of 86 weeks per participant.²

Causes, Signs, and Symptoms

Celiac disease is a chronic autoimmune disorder that is a reaction to eating gluten, which affects the small intestine. Gluten is found in a variety of foods that contain wheat, barley, or rye. Reactions caused by gluten intake could damage the small intestine’s lining and prevent nutrition absorption. Once the intestine is damaged, individuals could experience diarrhea, fatigue, weight loss, bloating, or anemia. Unrelated digestive symptoms include loss of bone density, an itchy, blistery skin rash, mouth ulcers, headaches, fatigue, nervous system injury, joint pain, reduced functioning of the spleen, and elevated liver enzymes.³

In children, celiac disease is more likely to cause digestive problems compared with adults. These can include nausea and vomiting, chronic diarrhea, a swollen stomach, constipation, gas, and pale, foul-smelling stools. Additionally, celiac disease tends to be more common in individuals who have a family member with celiac disease or dermatitis herpetiformis, type 2 diabetes, Down syndrome, Williams syndrome, Turner syndrome, autoimmune thyroid disease, microscopic colitis, or Addison disease, according to Mayo Clinic.³

Currently, there is no cure for celiac disease, and the only treatment option is a strict, lifelong gluten-free diet. However, even if adhering to a gluten-free diet, some individuals could still experience severe symptoms.^1,3

If the phase 2a study meets its primary and secondary end points of safety and efficacy, it could serve as a new treatment option to reduce the immune response to gluten caused by celiac disease, providing aid to the 1% of the global population impacted.¹

Pharmacists' Role in Celiac Disease Management

Pharmacists can play an essential role in managing individuals with celiac disease by providing counseling and education, identifying potential cases, managing medication, and guaranteeing adherence to treatment. In terms of medication management, pharmacists can ensure that prescription and non-prescription medications taken by individuals with celiac disease are gluten-free while monitoring potential drug-related issues.⁴

REFERENCES

1. Teva Celiac Disease Candidate Granted Fast Track Designation by US FDA. Teva. News release. May 27, 2025. Accessed May 30, 2025. https://www.tevapharm.com/news-and-media/latest-news/teva-celiac-disease-candidate-granted-fast-track-designation-by-us-fda/

2. Teva Branded Pharmaceutical Products R&D LLC. Updated May 22, 2025. Accessed May 30, 2025. A Trial to Assess the Efficacy and Safety of TEV-53408 in Adults With Celiac Disease. ClinicalTrials.gov Identifier: NCT NCT06807463. https://clinicaltrials.gov/study/NCT06807463

3. Celiac disease. Mayo Clinic. News release. September 12, 2023. Accessed May 30, 2025. https://www.mayoclinic.org/diseases-conditions/celiac-disease/symptoms-causes/syc-20352220#:~:text=Celiac%20disease%20is%20an%20illness,protein%20in%20your%20small%20intestine.

4. Mangione R., Patel P., October 2008. Accessed May 30, 2025. Caring for patients with celiac disease: The role of the pharmacist. https://www.japha.org/article/S1544-3191(15)31147-X/abstract#:~:text=Pharmacists%20can%20help%20reduce%20the,celiac%20disease%20with%20inappropriate%20remedies