The Food and Drug Administration (FDA) approved Lantidra, the first allogeneic (donor) pancreatic islet cell therapy derived from deceased donor pancreatic cells, for patients with with type 1 diabetes. Lantidra is indicated for adults with type 1 diabetes who cannot achieve target glycated haemoglobin levels due to recurrent episodes of severe hypoglycemia, despite intensive diabetes management and education.
Type 1 diabetes, an autoimmune indication, requires insulin treatment through multiple daily injections or continuous infusion via a pump. Individuals with type 1 diabetes frequently monitor their blood glucose levels to guide diabetes management.
Some individuals with type 1 diabetes struggle to maintain the appropriate insulin levels to avoid hyperglycemia while preventing hypoglycemia. They may also develop hypoglycemia unawareness, rendering them unable to detect dropping blood glucose levels and potentially leading to further complications. Lantidra offers a potential treatment option for such patients.
The primary mode of action of Lantidra is thought to be insulin secretion by the transplanted allogeneic islet beta cells. In certain patients with type 1 diabetes, these transplanted cells can produce sufficient insulin, eliminating the need for exogenous insulin administration to control blood sugar levels. Lantidra is administered as a single infusion into the hepatic portal vein, with additional infusions possible based on the patient's response.
The safety and effectiveness of Lantidra were evaluated in two non-randomized, single-arm studies involving 30 participants with type 1 diabetes and hypoglycemic unawareness. The results showed that 21 participants did not require insulin for one year or longer, with 11 maintaining independence from insulin for one to five years and 10 participants for more than five years. However, five participants did not achieve any days of insulin independence.
The adverse reactions associated with Lantidra varied among participants based on the number of infusions received and the duration of follow-up. The most common side effects were nausea, fatigue, anaemia, diarrhoea, and abdominal pain. Several participants experienced severe adverse reactions related to the infusion procedure and the use of immunosuppressive medications required to maintain the viability of the transplanted islet cells. In some cases, discontinuing immunosuppressive drugs led to the loss of islet cell function and insulin independence.
CellTrans is the market authorization holder of Lantidra.