Lantidra FDA Approval History

Last updated by Judith Stewart, BPharm on July 22, 2023.

FDA Approved: Yes (First approved June 28, 2023)
Brand name: Lantidra
Generic name: donislecel-jujn
Dosage form: Cellular Suspension for Infusion
Company: CellTrans, Inc.
Treatment for: Diabetes, Type 1

Lantidra (donislecel-jujn) is an allogeneic pancreatic islet cellular therapy for the treatment of type 1 diabetes mellitus in adults whose symptoms are not well controlled.

• Lantidra is indicated for the treatment of adults with type 1 diabetes who are unable to approach target HbA1c because of current repeated episodes of severe hypoglycemia despite intensive diabetes management and education. Lantidra is used in conjunction with concomitant immunosuppression.
• Type 1 diabetes is a chronic autoimmune disease that is treated with regular insulin injections. Many type 1 diabetes patients have trouble managing the amount of insulin needed every day, and dosing can become difficult. Lantidra provides a potential treatment option for these patients.
• Lantidra is thought to work in the treatment of type 1 diabetes via the secretion of insulin by the infused (transplanted) pancreatic beta-cells.
• Lantidra is administered as a single infusion into the hepatic portal vein. An additional infusion may be required depending on the patient’s response to the first dose.
• Warnings and precautions associated with Lantidra include increased risk of severe infections due to concomitant immunosuppression, procedural complications such as liver laceration and hemorrhage, increased risk for graft rejection, transmission of donor-derived infections, and elevation of panel reactive antibodies (PRA).
• Common adverse reactions include nausea, fatigue, anemia, diarrhea and abdominal pain.

Development timeline for Lantidra

Further information

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