Diamyd Medical seeks accelerated approval for diabetes treatment in the U.S

Diamyd Medical is pursuing an accelerated approval pathway in the U.S. for its immunotherapy, Diamyd® (rhGAD65/alum), which aims to preserve insulin production in patients with Stage 3 Type 1 Diabetes. The company plans to use interim results from the ongoing Phase 3 trial, DIAGNODE-3, as the basis for a Biologics License Application (BLA). Results from this interim readout are anticipated around March 2026, contingent on participant enrollment. The FDA has granted Fast Track designation for Diamyd® and acknowledged that accelerated approval could be sought based on significant treatment-related benefits on C-peptide levels, a key measure of insulin production. The Accelerated Approval Program allows for faster drug approval based on surrogate endpoints, which is crucial for addressing serious medical conditions. To prepare for the BLA submission, Diamyd Medical will conduct an interim study readout that includes efficacy data from approximately 170 participants who have completed their assessments, along with safety data from additional trial participants. The primary endpoint for this analysis will be C-peptide levels, which the FDA recognizes as a reliable predictor of clinical benefit. The DIAGNODE-3 trial is being conducted across eight European countries and the U.S., with a target recruitment of around 330 patients by the end of 2025. This trial focuses on recently diagnosed patients with Stage 3 Type 1 Diabetes who carry the HLA DR3-DQ2 genotype, a group that has shown responsiveness to Diamyd® in previous studies. The company is committed to working closely with the FDA to meet all regulatory requirements and expedite patient access to this promising treatment.