Swedish clinical-stage diabetes company Diamyd Medical (STO:DMYD-B) announced on Tuesday that it has received positive feedback from the US Food and Drug Administration (FDA) about an Accelerated Approval pathway for its immunotherapy, Diamyd, targeting Stage 3 Type 1 Diabetes patients with the HLA DR3-DQ2 genotype.
During a recent Type C Meeting, the FDA agreed that C-peptide could be used as a surrogate endpoint to predict the clinical benefit of preserving endogenous insulin production. This acknowledgment opens the possibility for Accelerated Approval based on significant treatment-related improvements in C-peptide levels due to Diamyd administration.
Ongoing discussions between Diamyd Medical and the FDA will clarify the requirements for a Biologics License Application (BLA) under this pathway, including an earlier readout from the ongoing Phase 3 DIAGNODE-3 trial.
Diamyd Medical focuses on precision medicine therapies for Type 1 Diabetes and LADA (Latent Autoimmune Diabetes in Adults). Diamyd has received Orphan Drug Designation and Fast Track Designation from the FDA for treating Stage 1, 2, and 3 Type 1 Diabetes.
The DIAGNODE-3 Phase III trial is currently recruiting patients with recent-onset Stage 3 Type 1 Diabetes in the US and eight European countries.
GSK PLC announces acceptance of NDA for gepotidacin by US FDA
Anixa Biosciences administers second dose of CAR-T therapy to individual patient
RevOpsis Therapeutics receives SBIR grant of over USD1.8m
AtomVie Global Radiopharma partners with Radiopharm Ventures
Lipella granted patent for innovative drug delivery technology
Adocia patents stable hormone combinations for obesity and diabetes
Accord BioPharma's IMULDOSA receives US FDA approval to treat chronic inflammatory conditions
RedHill Biopharma's opaganib selected for Ebola treatment development by BARDA
Quest Diagnostics acquires OhioHealth lab assets
Exelixis and Merck collaborate on clinical development of zanzalintinib
BD launches automated reagent kit to streamline single-cell discovery studies
Transgene's Phase II trial of TG4001 falls short of primary objective
GSK reports positive Phase III results for depemokimab in chronic rhinosinusitis with nasal polyps
SkylineDx reveals new data from the MERLIN_001 prospective US multi-centre trial