The U.S. Food and Drug Administration (FDA) has approved Lantidra, a cellular therapy made from deceased donor pancreatic cells, for the treatment of type 1 diabetes. Lantidra is intended for adults with type 1 diabetes who are unable to achieve target blood glucose levels due to severe hypoglycemia (low blood sugar) despite intensive management and education. Severe hypoglycemia can be dangerous and lead to loss of consciousness or seizures.
Type 1 diabetes is a chronic autoimmune disease that requires lifelong care, including insulin administration and frequent blood glucose checks. Some individuals with type 1 diabetes struggle to manage their insulin levels to prevent hyperglycemia (high blood sugar) without causing hypoglycemia. They may also develop hypoglycemia unawareness, where they are unable to detect dropping blood glucose levels. Lantidra offers a potential treatment option for these patients.
Lantidra works by infusing allogeneic islet beta cells, which secrete insulin, into the patient. In some patients, these infused cells can produce enough insulin to eliminate the need for daily insulin injections or pump use. The therapy is administered as a single infusion into the hepatic (liver) portal vein, and additional infusions may be performed based on the patient’s response.
The safety and effectiveness of Lantidra were evaluated in two non-randomized, single-arm studies involving 30 participants with type 1 diabetes and hypoglycemic unawareness. Overall, 21 participants did not need insulin for a year or more, with 11 participants reaching one to five years of insulin independence and 10 participants surpassing five years without needing insulin. However, some participants did not achieve any days of insulin independence.
Adverse reactions associated with Lantidra varied among participants, with common reactions including nausea, fatigue, anemia, diarrhea, and abdominal pain. Most participants experienced at least one serious adverse reaction related to the infusion procedure and the use of immunosuppressive medications required to maintain islet cell viability. Discontinuation of immunosuppressive medications led to loss of islet cell function and insulin independence. These adverse events should be considered when weighing the benefits and risks of Lantidra for each patient.
Lantidra is approved with patient-directed labeling to inform individuals with type 1 diabetes about its benefits and risks. The FDA granted approval to CellTrans Inc.
In summary, the FDA has approved Lantidra, a pancreatic islet cellular therapy, for the treatment of type 1 diabetes in adults who experience severe hypoglycemia despite intensive management. Lantidra allows some patients to achieve insulin independence by infusing allogeneic islet beta cells. However, the therapy comes with the risk of adverse reactions and requires the use of immunosuppressive medications. Patients should carefully consider the benefits and risks of Lantidra in consultation with their healthcare provider.
