CellTrans’ Donislecel: Insulin Independence Data May Offer Path To Market In Type 1 Diabetes

 
• By Sue Sutter

Proportion of subjects with freedom from exogenous insulin ‘might support the efficacy’ of the allogeneic islet cellular therapy, US FDA says after concluding that issues in two studies limit interpretability of primary analyses based on severe hypoglycemic events and HbA1c levels. An advisory committee will weigh clinical efficacy, safety and product characterization issues.

Pancreas secreting insulin
Restoration of insulin independence with pancreatic islet cell therapy would remove the risk of hypoglycemia from exogenous insulin. • Source: Shutterstock

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