FDA positively considers accelerated approval of Diamyd® in Type 1 Diabetes, recognizing C-peptide as a surrogate endpoint.
Diamyd Medical receives positive feedback from FDA regarding the potential accelerated approval of Diamyd® in Type 1 Diabetes. FDA acknowledges C-peptide as a surrogate endpoint to predict clinical benefits. Discussions are ongoing to determine BLA requirements for an Accelerated Approval pathway, including potential early readout of stimulated C-peptide from ongoing Phase 3 trial DIAGNODE-3.
July 23, 2024
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