The FDA has approved the Lantidra allogeneic pancreatic islet cellular therapy developed by CellTrans to treat diabetes.
This is the first approval of a donor pancreatic cellular therapy — made from deceased donor pancreatic cells — to treat Type 1 diabetes. The approval covers adults with Type 1 diabetes who are unable to approach targeted glycated hemoglobin because of repeated episodes of severe hypoglycemia.
Lantidra’s primary mechanism of action is believed to be the secretion of insulin by allogeneic islet beta cells infusion via the hepatic portal vein. An additional infusion may take place depending the patient’s response to the initial dose.
CellTrans tested the safety and effectiveness of Lantidra in two studies. A total of 30 participants with Type 1 diabetes and hypoglycemic unawareness received at least one infusion. Some received a maximum of three infusions. Overall, 21 participants did not have to take insulin for a year or more, with 11 not requiring insulin for between 1-5 years. Ten demonstrated no need to take insulin for more than five years. Five participants failed to achieve any days of insulin independence.
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