Letter to the FDA Urging the Agency Not to Approve the Biologics License Application for Donislecel for the Treatment of “Brittle” Type 1 Diabetes
Public Citizen urged the Food and Drug Administration (FDA) to not approve the biologics license application for donislecel (purified allogeneic deceased donor pancreas derived Islets of Langerhans) for the treatment of “brittle” type 1 diabetes because there is not adequate evidence showing that this product has a favorable benefit-risk profile and there are serious concerns regarding the quality controls for ensuring the potency and purity of each specific lot of donislecel.