First Allogeneic Pancreatic Islet Cellular Therapy Is Approved for Type 1 Diabetes

Lantidra has been approved by the US Food and Drug Administration (FDA) for adults with type 1 diabetes who are unable to achieve target glycated hemoglobin because of current repeated episodes of severe hypoglycemia despite intervention.

Lantidra is the first allogeneic pancreatic islet cellular therapy made from cadaver donor pancreatic cells for the treatment of type 1 diabetes.

The treatment is administered via hepatic infusion. Nausea, fatigue, anemia, diarrhea, and abdominal pain were the most common adverse reactions reported in clinical trials.

“Severe hypoglycemia is a dangerous condition that can lead to injuries resulting from loss of consciousness or seizures,” said Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research, via FDA press release.

“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.”

Reference:

FDA approves first cellular therapy to treat patients with type 1 diabetes. Press Release. US Food and Drug Administration. June 28, 2023. https://www.fda.gov/news-events/press-announcements/fda-approves-first-cellular-therapy-treat-patients-type-1-diabetes