FDA nod for first cellular therapy for type 1 diabetes

The US Food and Drug Administration yesterday approved Lantidra (donislecel), the first allogeneic (donor) pancreatic islet cellular therapy made from deceased donor pancreatic cells for the treatment of type 1 diabetes.

The approval of Lantidra was granted to privately-held |US biotech firm CellTrans, and comes two years after an FDA advisory committee agreed that the pancreatic islet cellular therapy had a favorable risk-benefit profile.

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.