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12-4 vote favors therapy for brittle form of type 1 diabetes.
An FDA advisory committee agreed that cadaveric allogeneic pancreatic islet cells (donislecel) for treating brittle type 1 diabetes is worth the risks for certain patients.
In a 12-4 vote Thursday with one abstention, members of the Cellular, Tissue, and Gene Therapies Advisory Committee felt that, although this procedure will likely benefit only a select few patients, the benefits of possible insulin independence for them outweigh the risks that come with long-term immunosuppressive treatment.
The therapy’s sponsor, CellTrans, explained that existing options are limited for the some 80,000 American adults estimated to have “brittle” type 1 diabetes — a subset of type 1 characterized by a particularly refractory form of complete insulin deficiency where patients often have vast swings in blood glucose levels.
Those existing therapies include whole-pancreas transplantation (with or without concurrent kidney transplant) or tried-and-true insulin therapy, which can come in the form of multiple daily injections or a closed-loop insulin pump and continuous glucose monitoring system.
“There are two very small sub-populations that it would provide the only viable therapy,” said Christopher Breuer, MD, of Nationwide Children’s Hospital in Columbus, Ohio, on why he voted in favor. “Those would be the ones who are eligible for transplantation but couldn’t tolerate a big operation… and those that were on the best standard-of-care — the feedback responsive pumps — but were not tolerating those.”