FDA Approves Lantidra, a Cellular Therapy for Type 1 Diabetes

The Food and Drug Administration (FDA) has approved Lantidra (donislecel-jujn) for the treatment of type 1 diabetes in adults who are unable to approach target HbA1c due to current repeated episodes of severe hypoglycemia despite intensive diabetes management and education. Treatment is to be used in conjunction with concomitant immunosuppression.

Lantidra is the first FDA-approved allogeneic pancreatic islet cellular therapy. It is believed to work through the secretion of insulin from the infused allogeneic islet beta cells. Treatment is administered as a single infusion into the hepatic portal vein. 

The approval was based on data from 2 prospective, open-label, single-arm studies that evaluated the efficacy and safety of donislecel in 30 adults with type 1 diabetes and hypoglycemic unawareness. Patients received at least 1 infusion and a maximum of 3 infusions of donislecel. Findings demonstrated that 25 patients achieved insulin independence, of which 4 were insulin independent for less than 1 year, 12 patients were insulin independent for 1 to 5 years, and 9 patients were insulin independent for more than 5 years. 

The safety profile of donislecel varied with each patient based on the number of infusions and length of time they were followed. The most common adverse reactions were nausea, fatigue, anemia, diarrhea and abdominal pain. It was reported that 90% of patients had at least 1 serious adverse reaction attributed to the infusion procedure (liver laceration/hematoma, and intra-abdominal bleeding; elevation of portal pressure) or immunosuppression (infection, malignancy). Safety and efficacy of Lantidra have not been established in patients with liver disease or renal failure, or in those who have received a renal transplant.

“Severe hypoglycemia is a dangerous condition that can lead to injuries resulting from loss of consciousness or seizures,” said Peter Marks, MD, PhD, 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.”

Lantidra is supplied as purified allogeneic islets of Langerhans suspended in buffered transplant medium. The product is contained in one 1000mL infusion bag with a supplied volume of 400mL, containing not more than 10cc of estimated packed islet tissue and not more than 1 x 10⁶ equivalent islet number (EIN).

According to the prescribing information, there is no evidence to support the use of Lantidra in patients whose diabetes is well controlled with insulin therapy or in patients with hypoglycemic unawareness who are able to prevent current repeated severe hypoglycemic events using intensive diabetes management. This should be considered when assessing the risks associated with the infusion procedure and use of long-term immunosuppression.