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The FDA has approved the first allogeneic pancreatic islet cell therapy, Lantidra, for the treatment of type 1 diabetes. Lantidra is approved with patient-directed labeling to inform patients with type 1 diabetes about the benefits and risks of Lanitdra. The FDA granted the approval of Lantidra to CellTrans Inc.
Lantidra has been approved for the treatment of type 1 diabetes in adults who due to current repeated episodes of severe hypoglycemia (low blood sugar), are unable to approach target glycated hemoglobin (average blood glucose levels) despite intensive diabetes management.
“Severe hypoglycemia is a dangerous condition that can lead to injuries resulting from loss of consciousness or seizures,” said Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research.
Type 1 diabetes requires lifelong care, requiring insulin through multiple daily injections or continuous daily infusion using a pump as well as regular checks of blood glucose levels as part of their management. Some individuals struggle to manage to control the amount of insulin needed daily to prevent high blood sugar without causing low blood sugar. Insulin is difficult to dose and where instances of hypoglycemia unawareness can affect some individuals, Lantidra can provide potential treatment options for these patients.
“Today’s approval, the first-ever cell therapy to treat patients with type 1 diabetes, provides individuals living with type 1 diabetes and recurrent severe hypoglycemia an additional treatment option to help achieve target blood glucose levels,” added Marks.
The primary mechanism action of Lantidra is believed to be the secretion of insulin by infused allogeneic islet beta cells. In some patients with type 1 diabetes, the infused cells can produce enough insulin to give the ability to the patient to control their blood sugar levels without the need for injections or the pump. The administration of Lantidra is a single infusion into the hepatic portal vein and if necessary, an additional infusion of Lantidra depending on the patient’s initial response to the first dose.
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The safety and effectiveness of Lantidra was evaluated in two non-randomized, single-arm studies. A total of 30 participants with type 1 diabetes and hypoglycemic unawareness received at least one infusion and maximum of three infusions. Overall, 21 participants did not need to take insulin for a year or more; 11 participants did not need insulin for one to five years, with 10 participants not needing insulin for more than five years. Five participants did not achieve any days of insulin independence.
Adverse reactions associated with Lantidra varied amongst each participant relative to the numbering of infusions they received and the duration and may not have reflected the rates observed in practice. Most participants experienced at least one serious adverse reaction related to the procedure for infusing Lantidra into the hepatic portal vein and the use of immunosuppressive medications needed to maintain the islet cell viability. Lantidra is approved with patient-directed labeling to inform patients with type 1 diabetes about the benefits and risks of Lantidra.
The FDA granted the approval of Lantidra to CellTrans Inc.
Source: FDA Press Release
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