The treatment landscape for type 1 diabetes has seen its most significant evolution in decades with the introduction of new therapies that move beyond simply replacing insulin. Unlike traditional management, these new approaches address the autoimmune nature of the disease, with the goal of delaying onset, preserving the body's own insulin production, or even potentially restoring it. Two of the most notable recent advancements are the drug Tzield (teplizumab) and the cellular therapy Lantidra.
Teplizumab (Tzield): The First Disease-Modifying Therapy
Tzield (teplizumab-mzwv) is a groundbreaking immunotherapy that received FDA approval in late 2022. It is the first drug of its kind approved to delay the onset of clinical (Stage 3) type 1 diabetes in people aged 8 years and older who are currently in Stage 2 of the disease.
How Tzield works
Teplizumab is a monoclonal antibody that acts on the immune system. Specifically, it works by binding to a protein called CD3 on the surface of T-cells, which are the immune cells responsible for attacking the pancreas in type 1 diabetes. By modifying these T-cells, the drug is able to delay their attack on the insulin-producing beta cells, effectively slowing the progression of the disease. This provides a critical window of time, delaying the eventual need for daily insulin injections.
Administration and results
- Administration: Tzield is administered via a 12-day intravenous infusion.
- Trial results: In clinical trials, it was shown to postpone the median onset of Stage 3 diabetes by an average of about two to three years.
- Expanded use: A separate Phase 3 trial (PROTECT) also demonstrated that teplizumab can help preserve beta-cell function in children and adolescents with new-onset (Stage 3) T1D, leading to reduced supplemental insulin needs and a lower risk of severe hypoglycemia.
Lantidra: A Cellular Therapy for Difficult-to-Manage Cases
Another significant development is the FDA approval of Lantidra in June 2023. Lantidra is a cellular therapy that provides patients with new insulin-producing cells.
How Lantidra works
Lantidra is an allogeneic pancreatic islet cellular therapy. This means the cells are sourced from the pancreatic islet cells of a deceased donor. The islets are infused into the hepatic portal vein of the recipient, where they can take up residence and begin producing and secreting insulin.
Indication and results
- Indication: It is approved for adults with type 1 diabetes who experience recurrent severe hypoglycemia despite intensive management.
- Insulin independence: In clinical studies, some participants were able to achieve insulin independence for a year or more, with some maintaining it for over five years.
- Limitations: The therapy is not without significant drawbacks, as it requires long-term use of immunosuppressive medications to prevent the body from rejecting the donor cells, similar to a solid organ transplant.
Promising Research: Baricitinib
Beyond approved therapies, research continues to find new ways to target the immune system. One notable candidate is baricitinib, an oral Janus kinase (JAK) inhibitor already approved for autoimmune disorders like rheumatoid arthritis. A recent study presented at the European Association for the Study of Diabetes in Vienna showed that baricitinib could preserve the body's own insulin production in people newly diagnosed with T1D. Patients saw their insulin production stabilize while on the pill, and it began to decline again once they stopped taking it, suggesting a continuous treatment might be necessary. This research highlights the potential for repurposing existing drugs to treat T1D, offering a potentially more convenient oral alternative to infusions or transplants.
A Comparative Look at New Type 1 Diabetes Medications
| Feature | Tzield (teplizumab) | Lantidra (allogeneic pancreatic islets) | Baricitinib (research) |
|---|---|---|---|
| Mechanism | Immunotherapy (monoclonal antibody targeting CD3 on T-cells) | Cellular therapy (transplanted donor islet cells) | Oral JAK inhibitor (immune system modulation) |
| Indication | Delaying Stage 3 T1D onset in Stage 2 patients (age 8+) | Recurrent severe hypoglycemia in adults with difficult-to-manage T1D | Newly diagnosed T1D to preserve insulin production (in study) |
| Administration | 12-day intravenous infusion | Hepatic portal vein infusion | Oral pill |
| Immunosuppression | Transient decrease in lymphocytes; no chronic immunosuppressants needed | Long-term, chronic immunosuppression required | Oral medication; side effects studied |
| Status | FDA-approved | FDA-approved | Research stage for T1D |
| Key Benefit | Buys time before diagnosis, potentially delaying lifelong insulin dependence | Potential for insulin independence in certain patients | Potential for easy oral administration to preserve beta cells |
The Shift from Management to Intervention
The most exciting aspect of these new therapies is the fundamental shift they represent. For over a century, type 1 diabetes treatment has been centered on managing the symptoms with insulin replacement. Now, clinicians have tools to intervene in the disease process itself. Tzield directly targets the immune system, slowing the destruction of beta cells, while Lantidra can potentially replace those lost cells. This intervention-focused approach is a game-changer, with the potential to reduce the long-term burden and complications associated with the disease.
Looking to the Future
The approval of Tzield and Lantidra is just the beginning. Researchers are actively exploring combinations of these and other treatments to enhance their effectiveness and duration. Potential future strategies include:
- Combination Therapies: Combining immunotherapies like teplizumab with other drugs or even cellular transplants could potentially create more robust, long-lasting effects.
- Expanded Use: Research is ongoing to see if immunotherapies like teplizumab could be used more broadly, such as in younger children or to better treat those with established disease.
- New Oral Agents: Continued research into oral medications like baricitinib could lead to more convenient, daily treatments for preventing or slowing progression.
- Improved Cellular Therapy: Innovations aim to reduce the need for chronic immunosuppression, which would make therapies like Lantidra accessible to a wider patient population.
Conclusion
While insulin remains the cornerstone of care for most people with type 1 diabetes, the recent breakthroughs with Tzield and Lantidra have expanded the therapeutic options dramatically. Tzield offers a way to delay the onset of the disease, particularly beneficial for at-risk individuals, while Lantidra provides a new avenue for adults with hard-to-manage T1D. Coupled with ongoing research into promising oral medications like baricitinib, the future of type 1 diabetes treatment is moving toward more preventative and disease-modifying strategies. These developments offer significant hope for improving the quality of life and long-term outcomes for those living with the condition. To learn more about the FDA's role and these approvals, visit the official FDA news page.
