FDA Approves Lantidra Cell Therapy for Type 1 Diabetes

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With an original PDUFA date in August 2021, the decision is a long time coming.

The FDA has approved CellTrans’ donislecel allogeneic pancreatic islet cell therapy under the name Lantidra, for treating adults with type 1 diabetes (T1D) who are unable to approach target glycated hemoglobin because of current repeated episodes of severe hypoglycemia despite intensive diabetes management and education.1

“Severe hypoglycemia is a dangerous condition that can lead to injuries resulting from loss of consciousness or seizures,” Peter Marks, MD, PhD, director, Center for Biologics Evaluation and Research, said in a statement.1 “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.”

Standard-of-care (SOC) treatment for T1D includes lifelong care of daily or continuous insulin administration alongside regular blood glucose checks. Unmet needs with SOC include hypoglycemia and hypoglycemia awareness. Donislecel is designed to secrete insulin, removing the need to take insulin to control blood sugar levels in some patients with T1D. The therapy is administered as a single infusion into the hepatic portal vein and an additional infusion may be given depending on the patient’s response to the initial dose.

The FDA approved donislecel based on safety and efficacy data from 30 participants in 2 open-label, single-arm studies (NCT03791567; NCT00679042) that received 1 to 3 infusions of donislecel.Investigators found that 21 participants did not have to take insulin for at least 1 year, 11 did not have to take insulin for 1 to 5 years, and 10 have not needed insulin for over 5 years. Five participants never achieved insulin independence.

In terms of safety, the most common adverse events (AEs) were nausea, fatigue, anemia, diarrhea, and abdominal pain. Most participants experienced at least 1 serious AE related to infusion or immunosuppression.

The decision has been a long time coming, with an original Prescription Drug User Fee Act date in August 2021. Earlier in 2021, donislecel was the subject of a Cellular, Tissue, and Gene Therapies Advisory Committee meeting, in which members voted 12-4 in favor of the therapy’s approval.2

REFERENCES
1. FDA Approves First Cellular Therapy to Treat Patients with Type 1 Diabetes. News release. FDA. June 28, 2023. https://www.fda.gov/news-events/press-announcements/fda-approves-first-cellular-therapy-treat-patients-type-1-diabetes
2. CTGTAC April 15, 2021 meeting announcement. U.S. Food and Drug Administration. Accessed June 28, 2023. https://www.fda.gov/advisory-committees/advisory-committee-calendar/cellular-tissue-and-gene-therapies-advisory-committee-april-15-2021-meeting-announcement-04152021
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