CellTrans obtains FDA OK for Lantidra

The Food and Drug Administration has granted permission to CellTrans for Lantidra, the first allogeneic (donor) pancreatic islet cellular therapy made from deceased donor pancreatic cells for the treatment of Type 1 diabetes.

Lantidra is approved for the treatment of 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) despite intensive diabetes management and education.

"Severe hypoglycemia is a dangerous condition that can lead to injuries resulting from loss of consciousness or seizures," said Peter Marks, director of the FDA's Center for Biologics Evaluation and Research. "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."

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Type 1 diabetes is a chronic autoimmune disease that requires lifelong care, including requiring insulin, either through multiple daily injections or continuous infusion using a pump, every day to live. People with Type 1 diabetes also perform blood glucose checks several times a day to guide the management of their diabetes.

Some people with Type 1 diabetes have trouble managing the daily insulin to prevent hyperglycemia (high blood sugar) without causing hypoglycemia. They also may develop hypoglycemia unawareness, where they cannot detect their blood glucose 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. Lantidra provides a potential treatment option for these patients.

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The primary mechanism of action of Lantidra is believed to be insulin secretion by the infused allogeneic islet beta cells. In some patients with Type 1 diabetes, these infused cells can produce enough insulin, so they no longer need 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. The FDA said that an additional infusion of Lantidra may be performed depending on the patient's response to the initial dose.