Named Lantidra, it's a cellular therapy developed using deceased donor pancreatic cells for the treatment of type 1 diabetes in adults.
“Severe hypoglycemia is a dangerous condition that can lead to injuries resulting from loss of consciousness or seizures,” said Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research, in an
The findings reported that 21 of the study candidates were not required to use insulin for at least a year or longer. Additionally, eleven individuals did not use insulin for one to five years, while ten for more than five years.
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FDA OKs Pancreatic Islet Cell Therapy for Type 1 DiabetesApproval of Lantidra, a beta cell therapy derived from donor pancreatic islets, came despite transplant surgeons' concerns about FDA regulating these cells as biologics rather than transplanted organs.
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