FDA approves first cell therapy to treat patients with type 1 diabetes

SILVER SPRING, Md., June 28, 2023 /PRNewswire/ — Today, the United States Food and Drug Administration approved Lantidra, the first allogeneic (donor) pancreatic islet cell therapy made from deceased donor pancreatic cells for the treatment of type 1 diabetes. the treatment of adults with type 1 diabetes who are unable to reach target glycated hemoglobin (average blood glucose levels) due to current repeated episodes of severe hypoglycaemia (low blood sugar) despite management and intensive diabetes education.

“Severe hypoglycemia is a dangerous condition that can lead to injury resulting from loss of consciousness or seizures,” he said Peter Mark, MD, Ph.D., director of the FDA’s Center for Biological Research and Evaluation. “Today’s approval, the first-ever cell therapy for the treatment of patients with type 1 diabetes, offers people with type 1 diabetes and recurrent severe hypoglycemia an additional treatment option to help achieve blood glucose levels target blood”.

Type 1 diabetes is a chronic autoimmune disease that requires lifelong care, including the need for insulin, either through multiple daily injections or continuous infusion using a pump, every day to live. People with type 1 diabetes also get blood sugar checks several times a day to guide the management of their diabetes.

Some people with type 1 diabetes have difficulty managing the amount of insulin they need each day to prevent hyperglycemia (high blood sugar) without causing low blood sugar. They may also develop hypoglycemia unawareness, in which they are unable to detect that their blood sugar is falling and may not be able to treat themselves to prevent their blood sugar from falling further. This makes it difficult to dose insulin. Lantidra offers a potential treatment option for these patients.

The primary mechanism of action of Lantidra is thought to be insulin secretion by the beta cells of the infused allogeneic islets. In some patients with type 1 diabetes, these infused cells can make enough insulin so the patient no longer needs to take insulin (by injection or pump) to control blood sugar levels. Lantidra is given as a single infusion into the hepatic portal vein (liver). A further infusion of Lantidra may be performed depending on the patient’s response to the initial dose.

The safety and efficacy of Lantidra were evaluated in two single-arm, non-randomised studies in which a total of 30 participants with type 1 diabetes and hypoglycemic unawareness received at least one and up to three infusions. Overall, 21 participants did not need 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.

Adverse reactions associated with Lantidra varied for each participant depending on the number of infusions received and the length of time they were followed and may not reflect the rates seen in practice. The most common adverse reactions included nausea, fatigue, anemia, diarrhea, and abdominal pain . Most participants experienced at least one serious adverse reaction related to the hepatic portal vein infusion procedure of Lantidra and the use of immunosuppressant drugs needed to maintain islet cell viability. Some serious adverse reactions have required discontinuation of immunosuppressive drugs, resulting in loss of islet cell function and insulin independence. These adverse events should be considered when evaluating the benefits and risks of Lantidra for each patient. Lantidra is approved with patient-facing labeling to educate patients with type 1 diabetes about the benefits and risks of Lantidra.

The FDA has granted approval of Lantidra to CellTrans Inc.

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The FDA, an agency within the United States Department of Health and Human Services, protects public health by ensuring the safety, efficacy, and safety of human and veterinary drugs, vaccines, and other biological products for human and medical devices. The agency is also responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that emit electronic radiation, and the regulation of tobacco products..

SOURCE US Food and Drug Administration