FDA Grants Fast Track Designation to Teva Celiac Disease Candidate

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 is being evaluated at present in a Phase IIa trial in order to assess its safety and efficacy in adults with celiac disease.

Addressing an unmet need

“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, in a company press release (1). “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 a monoclonal antibody intended to inhibit the activity of the cytokine IL-15, in order to prevent intestinal damage and other symptoms associated with celiac disease, which affects approximately 1% of the global population (1).

FDA and Teva both making moves

In April 2025, Teva Pharmaceuticals, the US-based affiliate of Teva Pharmaceutical Industries, made another significant announcement for the company, saying that it was partnering with Samsung Bioepis to launch eculizumab-aagh (under the brand name EPYSQLI), a biosimilar referencing eculizumab (brand name Soliris) (2). Eculizumab-aagh was approved by FDA in July 2024 to treat paroxysmal nocturnal hemoglobinuria and atypical hemolytic uremic syndrome, as well as in November 2024 to treat generalized myasthenia gravis in adult patients who are anti-acetylcholine receptor antibody positive, all difficult-to-treat rare diseases. The biosimilar is being offered at a 30% discount of the Wholesale Acquisition Cost of the reference biologic (2,3).

Also in April 2025, FDA granted another Fast Track designation, this one to a human anti-IL-7Rα antibody, bempikibart (ADX-914) made by Q32 Bio of Waltham, Mass., for the treatment of alopecia areata, a common, autoimmune skin disease characterized by hair loss, often in circular, coin-like patches, on the scalp as well as other areas of the face and body (4,5).

Fast Track status was designed by FDA to facilitate development and expedite review of certain drugs that are being formulated to treat serious conditions, addressing previously unmet medical needs (1).

References

1. Teva Pharmaceutical Industries. Teva Celiac Disease Candidate Granted Fast Track Designation by US FDA. Press Release. May 27, 2025.
2. Teva Pharmaceutical Industries. Teva and Samsung Bioepis Announce Biosimilar EPYSQLI (eculizumab-aagh) Injection Now Available in the United States. Press Release. April 7, 2025.
3. Mirasol, F. Teva and Samsung Bioepis Launch Biosimilar Eculizumab in US Market. BioPharmInternational.com, April 17, 2025.
4. Q32 Bio. Q32 Bio Announces FDA Fast Track Designation Granted to Bempikibart (ADX-914) for the Treatment of Alopecia Areata. Press Release. April 30, 2025.
5. Alopecia Areata. National Alopecia Areata Foundation | NAAF. NAAF.org (accessed May 30, 2025).