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FDA approval of Lantidra offers hope to adults suffering from type 1 diabetes who struggle with severe hypoglycemia, despite intensive management efforts.
On 28 June 2023, the U.S. Food and Drug Administration (FDA) granted approval to Lantidra, a groundbreaking allogeneic pancreatic islet cellular therapy, as a treatment for type 1 diabetes. Lantidra, derived from deceased donor pancreatic cells, offers a new option for adults with diabetes who experience repeated severe hypoglycemia despite intensive diabetes management and education.
Severe hypoglycemia, characterized by low blood sugar levels, can lead to unconsciousness or seizures, making it a potentially life-threatening condition. According to Dr. Peter Marks, director of the FDA's Center for Biologics Evaluation and Research, Lantidra's approval marks a significant milestone as the first-ever cell therapy for patients suffering from type 1 diabetes, providing them with an additional treatment avenue to attain target blood glucose levels.
Living with type 1 diabetes means managing a chronic autoimmune disease for life, which typically involves daily insulin injections or using a pump for continuous insulin infusion. Patients must vigilantly monitor their blood glucose levels to regulate their condition effectively. Lantidra addresses the challenges faced by diabetic patients who struggle to strike the right balance between insulin doses, often leading to fluctuations in blood sugar levels.
In certain cases, individuals may develop a condition called hypoglycemia unawareness, wherein they are unable to timely detect the decline in their blood glucose levels, making it challenging to take proactive measures to prevent hypoglycemia. Lantidra represents a potential therapeutic option for such patients. The key mode of action revolves around the secretion of insulin by the transplanted allogeneic islet beta cells. In a few cases, these infused cells can generate sufficient insulin, eliminating the need for exogenous insulin administration.
The treatment involves a single infusion into the hepatic portal vein, with additional infusions possible based on individual patient response. To evaluate its safety and efficacy, two non-randomized, single-arm studies were conducted involving 30 subjects having type 1 diabetes and hypoglycemic unawareness. The results indicated that 21 subjects achieved insulin independence for 1 year or more. Among them, 11 subjects remained independent for one to five years, while 10 subjects maintained insulin independence for over five years. However, five subjects did not attain any days of insulin independence.
Adverse reactions to Lantidra varied among participants, based on the duration of follow-up and the number of infusions. Common side effects encompassed abdominal pain, diarrhea, anemia, fatigue, and nausea. Moreover, a number of volunteers encountered severe adverse effects associated with the infusion procedure performed in the hepatic portal vein and the necessary administration of immunosuppressive medications to sustain the viability of the islet cells. Ceasing the usage of immunosuppressive drugs resulted in the decline of islet cell function and the loss of independence from exogenous insulin.
These factors emphasize the importance of carefully evaluating the benefits and risks of Lantidra on a case-by-case basis. Lantidra has been approved with patient-directed labeling to ensure that individuals with type 1 diabetes are informed about its benefits and risks. Its approval represents a significant advancement in diabetes management, offering renewed hope for patients who struggle with managing their blood sugar levels and experiencing severe hypoglycemia.
US-FDA
FDA Approves First Cellular Therapy to Treat Patients with Type 1 Diabetes
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