The first cellular therapy for type 1 diabetes was approved by the US Food and Drug Administration (FDA) on 28 June. The drug, called Lantidra, is an infusion of insulin-producing pancreatic cells from a deceased donor. It is the first treatment approved for people with type 1 diabetes who cannot regulate their blood sugar levels using standard insulin shots or infusions.
Type 1 diabetes is a chronic condition in which the body’s immune system mistakenly attacks cells in the pancreas that produce insulin. The hormone helps stabilise blood sugar levels by moving glucose out of the blood and into cells for energy. People with the condition must check their blood sugar levels several times a day and administer insulin accordingly to keep these levels in a safe range.
However, some people with type 1 diabetes struggle to prevent high blood sugar levels using insulin without overcorrecting to overly low blood sugar levels, causing hypoglycaemia. Others can also develop hypoglycaemia unawareness, which is when someone is unable to notice drops in blood sugar and, as a result, cannot intervene to stop it from falling even further.
“Severe hypoglycemia is a dangerous condition that can lead to injuries resulting from loss of consciousness or seizures,” said Peter Marks at the FDA’s Center for Biologics Evaluation and Research in a press release. “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 a single infusion that delivers donor pancreatic cells into the main vein of the liver. Those who receive it must take immunosuppressing medications to prevent their immune system from damaging the donor cells, which secrete insulin. It is currently approved for adults with type 1 diabetes who experience repeated episodes of severely low blood sugar despite intense diabetes management and education.
The FDA made its decision based on two clinical trials in which 30 participants received between one and three infusions of the drug. About 70 per cent of them no longer needed to take insulin for a year or more after the infusion, and 30 per cent did not need to take it for more than five years.