FDA approves cellular therapy for patients with Type 1 diabetes

The U.S. Food and Drug Administration (FDA) has now approved Lantidra, the first allogeneic (donor) pancreatic islet cellular therapy made from deceased donor pancreatic cells for use in the treatment of Type 1 diabetes.

Lantidra is approved for use with adults with Type 1 diabetes who are unable to approach target glycated hemoglobin (average blood glucose levels) because of current repeated episodes of severe hypoglycemia (low blood sugar). Some people with Type 1 diabetes have trouble managing the amount of insulin needed every day to prevent hyperglycemia (high blood sugar) without causing hypoglycemia. They may also develop hypoglycemia unawareness, where they are unable to detect their blood glucose is dropping and may not have a chance to treat themselves to prevent their blood glucose from further dropping. This makes it difficult to dose insulin, and Lantidra provides a potential treatment option for these patients.

The primary mechanism of action of Lantidra is believed to be the secretion of insulin by infused allogeneic islet beta cells. In some patients with Type 1 diabetes, these infused cells can produce enough insulin, so the patient no longer needs to take insulin (by injections or pump) to control their blood sugar levels.

Lantidra is administered as a single infusion into the hepatic (liver) portal vein. An additional infusion of Lantidra may also be performed depending on the patient’s response to the initial dose.

To find out more, CLICK HERE.


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