The US Food and Drug Administration (FDA) has approved CellTrans’ Lantidra (donislecel) as the first cellular therapy to treat patients with type 1 diabetes.
The authorisation specifically applies to adults who are unable to meet their target blood glucose levels because they have repeated episodes of severe low blood sugar (hypoglycaemia), despite intensive disease management and education.
Almost 1.9 million people in the US have type 1 diabetes, according to the American Diabetes Association. The condition requires lifelong care, including the regular administration of insulin, either through multiple daily injections or continuous infusion using a pump.
However, some patients have trouble managing the amount of insulin needed every day, and dosing becomes difficult. These patients may also develop hypoglycaemia unawareness, where they are unable to detect that their blood glucose is dropping and may not have a chance to treat themselves.
Lantidra, which is administered initially as a single infusion, aims to replace the insulin-producing beta cells in the pancreas, reducing the need for patients to take insulin to control their blood sugar levels.
The therapy was evaluated in two single-arm studies in which 30 patients with type 1 diabetes and hypoglycaemic unawareness received one to three infusions.
Overall, 21 patients did not need to take insulin for a year or more, with 11 not needing insulin for one to five years and ten not needing insulin for more than five years.
However, the FDA noted that the majority of patients involved in the study experienced at least one serious adverse reaction, some of which required immunosuppressants to be discontinued, leading to the loss of the transplanted beta cells.
Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, said: “Severe hypoglycaemia is a dangerous condition that can lead to injuries resulting from loss of consciousness or seizures.
“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.”