FDA approves world's first cellular therapy for type-1 diabetes

For those patients, Lantidra could be a potential treatment option to maintain their glucose levels. 

“Severe hypoglycemia is a dangerous condition that can lead to injuries resulting from loss of consciousness or seizures,” said Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research, in an official release. 

Marks added: “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.”

How the therapy is administered  

The new treatment works by administering infused donor islet beta cells (insulin-secreting cells) to release insulin in patients.

The medication is administered as a single infusion into the hepatic (liver) portal vein. According to the FDA, the second infusion of the medicine may be administered based on the patient's response to the first dosage. 

Lathindra, developed by CellTrans Inc., has undergone rigorous clinical trials before approval. 

“The safety and effectiveness of Lantidra were evaluated in two non-randomized, single-arm studies in which a total of 30 participants with type 1 diabetes and hypoglycemic unawareness received at least one infusion and a maximum of three infusions,” noted the press release. 

The findings reported that 21 of the study candidates were not required to use insulin for at least a year or longer. Additionally, eleven individuals did not use insulin for one to five years, while ten for more than five years. 

Regarding treatment side effects, the reaction varied from person to person. This was determined mainly by the infusion dosages used, the dose gap, and other factors. 

Nausea, exhaustion, anemia, diarrhea, and stomach discomfort were the most prevalent reactions noticed among the participants. Most participants reported at least one severe adverse response associated with the procedure for administering therapy into the vein.  

“Lantidra is approved with patient-directed labeling to inform patients with type 1 diabetes about benefits and risks of Lantidra,” concluded the FDA.