The FDA USA has approved Lantidra (donislecel), a revolutionary treatment for people with type 1 diabetes. Lantidra works by restoring the body’s beta cells, potentially eliminating the need for external insulin.
The FDA has approved Lantidra (donislecel), a revolutionary treatment for people living with type 1 diabetes. Lantidra works by restoring the body’s beta cells, potentially eliminating the need for external insulin.
Lantidra (donislecel), a cell therapy that helps to restore functional pancreatic islet cells in patients unable to produce insulin, has become the first cell therapy to ever be approved by the FDA for people with type 1 diabetes.
Donislecel, which has been developed by the startup CellTrans under the brand name Lantidra,
offers a potential solution for people with T1D by introducing insulin-producing pancreatic islet beta cells from donors, reducing or eliminating the need for external insulin administration. The treatment has been approved for people with type 1 diabetes who struggle with severe hypoglycemia.
“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 hypoglycaemia an additional treatment option to help achieve target blood glucose levels,” Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, said.
How does Lantidra work?
Lantidra is made from pancreatic cells obtained from deceased donors. These cells, known as allogeneic islet beta cells, have the ability to produce and secrete insulin. When Lantidra is infused into the body, specifically into the hepatic portal vein, it allows the islet beta cells to enter the bloodstream and reach the liver. Additionally, immunosuppressive medications are needed to maintain the transplanted islet cells’ viability.
Once inside the liver, the new infused islet beta cells begin to secrete insulin. If the infused cells produce enough insulin for the body, they can regulate blood glucose levels without the need for additional insulin injections or pumps.
In a clinical study of 30 participants with T1D and hypoglycemia unawareness, 21 participants did not have to use external insulin for one year or longer. Among them, 11 individuals maintained independence for one to five years, while 10 participants remained insulin-free for more than five years. However, it is important to note that not all participants experienced the same level of success, and some did not achieve any days of insulin independence.
Who is Lantidra for?
At this time, Donislecel is specifically only approved for people with type 1 diabetes who experience level 3 hypoglycemia. “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,” the FDA said in a June 28 statement.
People with type 1 diabetes (T1D) rely on external insulin administration, leading some to experience hypoglycemia unawareness, or the inability to detect when blood glucose levels are dropping, which can make dosing insulin especially challenging.
Side effects of Lantidra
Common side effects of Lantidra include nausea, fatigue, anemia, diarrhea, and abdominal pain. Some participants experienced serious adverse reactions, primarily related to the infusion procedure and the use of immunosuppressive medications. Discontinuation of these medications, in some cases, resulted in the loss of islet cell function and a return to dependence on external insulin. Lantidra comes with “patient directed labeling” so that people with diabetes can understand the potential benefits and risks of treatment.
To learn more about type 1 diabetes prevention and treatment, read our other articles:
- FDA Approves Tzield (Teplizumab) to Delay Type 1 Diabetes
- https://diatribe.org/fda-approves-tzield-teplizumab-delay-type-1-diabetes
- Screening and Prevention of Type 1 Diabetes
- https://diatribe.org/screening-and-prevention-type-1-diabetes
- Stem Cells and the Search For a Type 1 Diabetes Cure
- https://diatribe.org/stem-cells-and-search-type-1-diabetes-cure
- New Vertex Type 1 Stem Cell Therapy Gets FDA Nod to Enter Clinical Trials
- https://diatribe.org/new-vertex-type-1-stem-cell-therapy-gets-fda-nod-enter-clinical-trials
- ViaCyte and CRISPR Introduce New Stem Cell Therapy for Type 1 Diabetes
- https://diatribe.org/viacyte-and-crispr-introduce-new-stem-cell-therapy-for-type-1-diabetes
FDA Approves First Cellular Therapy to Treat Patients with Type 1 Diabetes
Today, the U.S. Food and Drug Administration approved Lantidra, the first allogeneic (donor) pancreatic islet cellular therapy made from deceased donor pancreatic cells for the treatment of type 1 diabetes.
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.
“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.
- “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.”
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 live. 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. They may also develop hypoglycemia unawareness, where they are unable to detect their blood glucose is dropping and may not have a chance to treat themselves to prevent their blood glucose from further dropping. This makes it difficult to dose insulin. Lantidra provides a potential treatment option for these patients.
The primary mechanism of action of Lantidra is believed to be the secretion of insulin by the infused allogeneic islet beta cells. In some patients with type 1 diabetes, these infused cells can produce enough insulin, so the patient no longer needs to take insulin (by injections or pump) to control their blood sugar levels. Lantidra is administered as a single infusion into the hepatic (liver) portal vein. An additional infusion of Lantidra may be performed depending on the patient’s response to the initial dose.
The safety and effectiveness of Lantidra was evaluated in two non-randomized, single-arm studies in which a total of 30 participants with type 1 diabetes and hypoglycemic unawareness received at least one infusion and a maximum of three infusions. Overall, 21 participants did not need to take 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 with each participant depending on the number of infusions they received and the length of time they were followed and may not reflect the rates observed in practice The most common adverse reactions included nausea, fatigue, anemia, diarrhea and abdominal pain.
A majority of participants experienced at least one serious adverse reaction related to the procedure for infusing Lantidra into the hepatic portal vein and the use of immunosuppressive medications needed to maintain the islet cell viability.
Some serious adverse reactions required discontinuation of immunosuppressive medications, which resulted in the loss of islet cell function and insulin independence. These adverse events should be considered when assessing the benefits and risks of Lantidra for each patient. Lantidra is approved with patient-directed labeling to inform patients with type 1 diabetes about benefits and risks of Lantidra.
The FDA granted approval of Lantidra to CellTrans Inc.
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.
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