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CellTrans’ Donislecel Gets US FDA Panel Nod For Small Group Of Type 1 Diabetics

 
• By Sue Sutter

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.

Independence Day fireworks
Some recipients of CellTrans' donislecel are able to celebrate years of independence from insulin. • Source: Alamy

CellTrans, Inc.’s donislecel has a favorable benefit-risk profile for some type 1 diabetics, but the US Food and Drug Administration needs to carefully and narrowly define the small group of patients that should be eligible for the therapy, members of the Cellular, Tissue and Gene Therapies Advisory Committee said on 15 April.

The majority of panel members said the benefits of independence from insulin seen in the majority of patients across CellTrans’ two clinical trials outweighed the risks from long-term immunosuppression necessary...

Advisory Committee Vote
  • Does donislecel delivered by intraportal administration have an overall favorable benefit-risk profile for some patients with type 1 diabetes? Y – 12, N – 4, Abstain –...

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