FDA Approves Breakthrough Cellular Therapy for Type 1 Diabetes Treatment
Thursday, June 29, 2023
The U.S. Food and Drug Administration (FDA) has approved Lantidra as the first cellular therapy for the treatment of type 1 diabetes. Lantidra utilizes allogeneic pancreatic islet cells from deceased donors. It is specifically indicated for adults with type 1 diabetes who experience severe hypoglycemia despite intensive diabetes management.
Type 1 diabetes is a chronic autoimmune disease that necessitates lifelong care and insulin administration. Some individuals with type 1 diabetes struggle to maintain optimal blood glucose levels, leading to recurring episodes of low blood sugar. Lantidra offers an additional treatment option for such individuals to help achieve target blood glucose levels.
Lantidra works by infusing allogeneic islet beta cells, which secrete insulin, into the patient's body. In some cases, these transplanted cells can produce sufficient insulin, reducing or eliminating the need for exogenous insulin through injections or pumps. The therapy is administered through a single infusion into the hepatic portal vein, with additional infusions performed based on the patient's response.
The approval of Lantidra followed evaluations conducted in non-randomized, single-arm studies involving 30 participants with type 1 diabetes and hypoglycemic unawareness. The results demonstrated that a majority of participants achieved insulin independence for varying durations, ranging from one to more than five years. However, it is important to note that adverse reactions were observed, including nausea, fatigue, anemia, diarrhea, abdominal pain, and serious adverse events associated with the infusion procedure and immunosuppressive medications.
Lantidra's approval includes patient-directed labeling that provides comprehensive information on its benefits and risks for individuals with type 1 diabetes.