On June 28, 2023, 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 HbA1C because of current repeated episodes of severe hypoglycemia despite intensive diabetes management and education. Use in conjunction with concomitant immunosuppression.[i]
Prevalence of Type I Diabetes in the United States:
37.3 million people, or 11.3% of the U.S. population, have diabetes. An estimated 28.7 million people – or 28.5% of the population – had diagnosed diabetes. Approximately 8.5 million people have diabetes but have not yet been diagnosed (2022).ii
Diabetes impacts all social, economic, and ethnic backgrounds.ii
1.45 million Americans are living with T1D, which accounts for about 3.75% of all diagnosed cases of diabetes[ii].
1.6 million adults aged 20 years or older—or 5.7% of all US adults with diagnosed diabetes—reported both having type 1 diabetes and using insulin.[iii]
Brittle diabetes affects three out of every 1000 people with type 1 diabetes.[iv]
According to the FDA press release:
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.[v]
It is important to note that 90% of all subjects in the clinical trials experienced at least one serious reaction related to infusion into the hepatic portal vein and immunosuppression.
The major causes of the reactions were related to: [vi]
Infusion procedure
liver laceration/hematoma, hemorrhage, and intra-abdominal bleeding (13%)
elevation of portal pressure (7%)
Immunosuppression
Infection (87%)
Malignancy (37%)
According to the FDA Summary Report dated June 28, 2023: “Each lot of Lantidra is manufactured from a deceased donor pancreas procured via the Organ Procurement and Transplantation Network (OPTN) and is for the treatment of one patient. The manufacturing facility is located at University Illinois Health (UIH) campus, which is a 5-minute walk to the UIH Department of Radiology within the same building. The entire contents of both the Lantidra bag and the Rinse bag are infused into the patient’s hepatic portal vein by an interventional radiologist experienced in islet cell portal administration in one of the interventional radiology suites within UIH Department of Radiology.” [vii]
Lantidra must be used with immunosuppressive drugs to prevent the body from rejecting the transplanted cells. In cases that immunosuppressive therapy was discontinued, the transplanted islet cells no longer worked.[viii]
Article by Kathy Clark, RN, BSN, CMCN, Vice President, Director of Managed Care. For more information about how this may affect your plan, please contact your Summit ReSources care specialist. The following sources were used as reference material for this article:
[i] FDA approves first cellular therapy to treat patients with type 1 diabetes. US Food and Drug Administration. Accessed July 17, 2023. https://www.fda.gov/news-events/press-announcements/fda-approves-first-cellular-therapy-treat-patients-type-1-diabetes
[ii] Diabetes Statistics. Diabetes Research Institute. Accessed July 17, 2023. https://diabetesresearch.org/diabetes-statistics/#:~:text=Diabetes%20is%20increasing%20at%20an,included%20in%20the%20CDC's%20report.
[iii] Prevalence of Diagnosed Diabetes. Centers for Disease Control and Prevention. Accessed July 17, 2023. https://www.cdc.gov/diabetes/data/statistics-report/diagnosed-diabetes.html
[iv] What is Brittle Diabetes? Diabetes Self-Management. Accessed July 25, 2023. https://www.diabetesselfmanagement.com/healthy-living/general-health/what-is-brittle-diabetes/
[v]FDA approves first cellular therapy to treat patients with type 1 diabetes. US Food and Drug Administration. Accessed July 17, 2023. https://www.fda.gov/news-events/press-announcements/fda-approves-first-cellular-therapy-treat-patients-type-1-diabetes
[vi] Lantidra. Package insert. CellTrans; 2023. Accessed July 25, 2023, 2023. https://www.fda.gov/media/169920/download
[vii] June 28, 2023 Summary Basis for Regulatory Action – LANTIDRA. US Food and Drug Administration. Accessed July 25, 2023. https://www.fda.gov/media/170457/download?attachment
[viii] FDA Approval Type 1 Diabetes Cell Therapy. Accessed July 25, 2023. https://medcitynews.com/2023/07/fda-approval-type-1-diabetes-cell-therapy/