FDA approves first cellular therapy for type 1 diabetes

Woman uses Digital Glucose meter

The US Food and Drug Administration has approved CellTrans’ 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 haemoglobin (average blood glucose levels) because of current repeated episodes of severe hypoglycaemia (low blood sugar) despite intensive diabetes management and education.

“Severe hypoglycaemia 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 hypoglycaemia an additional treatment option to help achieve target blood glucose levels.”

Lantidra provides a potential treatment option for patients with type 1 diabetes who have trouble managing the amount of insulin needed every day to prevent hyperglycaemia (high blood sugar) without causing hypoglycaemia.

The primary mechanism of action of Lantidra is believed to be the secretion of insulin by the 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.

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

Insulin independent for five years

The safety and effectiveness of Lantidra was evaluated in two non-randomised, single-arm studies in which a total of 30 participants with type 1 diabetes and hypoglycaemic unawareness received at least one infusion and a maximum of three infusions.

Overall, 21 participants did not need to take insulin for a year or more, with 11 participants not needing insulin for one to five years and 10 participants not needing insulin for more than five years. Five participants did not achieve any days of insulin independence.

A majority of 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. As a result, Lantidra is approved with labelling to inform patients about the benefits and risks.

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