The U.S. Food and Drug Administration has approved Lantidra, a cellular therapy medication used for the treatment of type 1 diabetes.
The FDA granted approval of Lantidra to Chicago-based biotech CellTrans Inc.
Lantidra is approved for treating adult diabetic patients who are unable to approach target average blood glucose levels because of repeated episodes of severe low blood sugar leves.
Donislecel, sold under the brand name Lantidra, is the first allogeneic pancreatic islet cellular therapy, consisting of insulin-producing islet beta cells made from the pancreatic cells of a deceased donor.
Severe hypoglycemia in type 1 diabetes patients is very rare, affecting only around three in every 1,000 people with insulin-dependent diabetes, but is a dangerous condition that can lead to injuries resulting from loss of consciousness or seizures.
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 survive. 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 amount of insulin needed every day to prevent hyperglycemia (high blood sugar) without causing hypoglycemia.
Lantidra aims to replace the insulin-producing beta cells in the pancreas, reducing the need for insulin injections and providing a background level of insulin secretion that can help to prevent the swings between low and high blood glucose seen in unstable type 1 diabetes.
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