CellTrans’ Donislecel Gets US FDA Panel Nod For Small Group Of Type 1 Diabetics
Benefits of independence from exogenous insulin outweighed the risks from long-term immunosuppression necessary with the allogeneic pancreatic islet cellular therapy, majority of panelists said, but they urged the FDA to limit the indication to a very small subpopulation of patients.
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Recent And Upcoming FDA Advisory Committee Meetings
Recent and upcoming US FDA advisory committee meetings and a summary of topics covered.
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.