The U.S. Food and Drug Administration has approved Lantidra, a novel therapy for brittle type 1 diabetes, offering a new treatment option for adults struggling with blood sugar control. This pancreatic islet cell therapy, derived from a deceased donor pancreas, is designed to regulate blood glucose by infusing insulin-producing cells into the patient's liver.
Clinical Efficacy and Outcomes
Clinical trials supporting Lantidra's approval demonstrated promising results. According to Dr. Enrico Benedetti, head of surgery at UI Health, 70% of patients who received Lantidra no longer required insulin one year post-transplant, and over 90% experienced no hypoglycemia. These findings highlight the potential for Lantidra to significantly reduce or eliminate the need for external insulin and improve glycemic control in individuals with brittle type 1 diabetes.
Mechanism of Action and Procedure
Lantidra involves transplanting islet cells from a deceased donor's pancreas into the recipient's liver. These cells then lodge in the liver's small blood vessels and begin producing insulin. Patients undergoing Lantidra therapy must take immunosuppressant drugs to prevent rejection of the islet cells. The success of the treatment can vary, and some patients may require more than one infusion of donor islet cells.
Eligibility and Availability
Lantidra is available exclusively at UI Health in Chicago. Eligible patients must be 18 years or older, have type 1 diabetes for more than five years, be insulin-dependent, and have a body mass index below 27. They also need to have experienced a severe episode of low blood sugar in the past three years or severe hypoglycemia unawareness, despite insulin management. Patients should have no other serious health problems affecting their heart, lungs, liver, or brain, and no active infections.
Investigational Therapy with Tegoprubart
In related news, a clinical trial is testing tegoprubart, a new monoclonal antibody, after islet cell transplant. Early data presented at the 5th Summit on Stem Cell Derived Islets showed that the first two recipients achieved insulin independence and normal hemoglobin A1C levels. The third recipient decreased insulin use by more than 60% three days following the procedure. This investigational therapy aims to replace older antirejection drugs and potentially improve graft survival and function.
Expert Commentary
Dr. José Oberholzer, founder and president of CellTrans Inc., described Lantidra as "the culmination of more than 20 years of collaborative work," emphasizing the significance of the FDA approval. Dr. Piotr Witkowski, director of the Pancreas and Islet Transplant Program at University of Chicago Medicine, noted that the data from the tegoprubart trial are "another step in our quest to achieve a path for functional cures in type 1 diabetes."
Disease Burden and Unmet Needs
Type 1 diabetes affects over 1.4 million people in the United States, with approximately 80,000 suffering from brittle type 1 diabetes. This severe form of the disease can lead to blindness, kidney failure, limb amputation, stroke, and heart attack. Lantidra addresses a critical unmet need by providing a treatment option that can reduce or eliminate the need for insulin injections and improve the quality of life for those with brittle type 1 diabetes.
