CellTrans, Inc. has not adequately demonstrated that donislecel reduces the incidence of severe hypoglycemic events or improves glycemic control in a subpopulation of type 1 diabetics, but the allogeneic pancreatic islet cellular therapy can provide prolonged insulin independence for some patients, the US Food and Drug Administration said.
CellTrans’ Donislecel: Insulin Independence Data May Offer Path To Market In Type 1 Diabetes
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.
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