FDA Approves First Cellular Therapy to Treat Patients with Type 1 Diabetes

FDA Approves First Cellular Therapy to Treat Patients with Type 1 Diabetes

The U.S. Food and Drug Administration (FDA) has given its approval for Lantidra, the first cellular therapy made from deceased donor pancreatic cells, to treat patients with type 1 diabetes. Lantidra is specifically intended for adults with type 1 diabetes who have been unable to achieve their target glycated hemoglobin levels due to repeated episodes of severe hypoglycemia, despite intensive treatment and education. Some individuals with type 1 diabetes struggle to control their insulin levels, leading to difficulties in managing blood sugar levels. Lantidra offers a potential treatment option for these patients.

Lantidra works by releasing insulin through the infusion of allogeneic islet beta cells. In certain patients with type 1 diabetes, these infused cells can produce enough insulin to eliminate the need for regular insulin injections or pumps. The therapy is administered through a single infusion into the hepatic portal vein, with additional infusions possible depending on the patient's response.

The safety and effectiveness of Lantidra were evaluated in two non-randomized studies involving 30 participants with type 1 diabetes and hypoglycemic unawareness. Out of these participants, 21 were able to go without insulin for a year or longer, with 11 of them achieving this for one to five years and 10 for more than five years. However, five participants did not achieve any days of insulin independence.

Adverse reactions to Lantidra varied among participants, depending on the number of infusions and duration of follow-up. The most common adverse reactions included nausea, fatigue, anemia, diarrhea, and abdominal pain. Many participants experienced at least one serious adverse reaction related to the infusion procedure and the use of immunosuppressive medications required to maintain the viability of the islet cells. In some cases, discontinuation of immunosuppressive medications resulted in the loss of islet cell function and insulin independence. These potential side effects should be considered when weighing the benefits and risks of Lantidra for each patient. The FDA has approved Lantidra with patient-directed labeling to provide information on its benefits and risks for individuals with type 1 diabetes.

The approval for Lantidra was granted to CellTrans Inc.

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