> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# Diamyd Granted Fast Track for Diabetes
- URL: https://www.fdaweb.com/diamyd-granted-fast-track-for-diabetes/
- Published: 2024-07-19T12:00:00.000Z
- Updated: 2026-09-14T14:35:57.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5157393

FDA has granted Diamyd Medical a Fast Track designation for Diamyd (rhGAD65/alum) for use in treating Type 1 diabetes in pediatric patients with Stage 1 or Stage 2 Type 1 diabetes carrying the genotype HLA DR3-DQ2\. Earlier this year, Diamyd was granted fast track for treating Stage 3 Type 1 diabetes (T1D) carrying the HLA DR3-DQ2 genotype.

Those with Stage 1 T1D have tested positive for two or more diabetes-related autoantibodies but still have normal blood glucose values and no symptoms of the disease, according to the company. Individuals with Stage 2 T1D have progressed to abnormal blood glucose values (dysglycemia) and are usually asymptomatic. “Stage 3 T1D is synonymous with clinically diagnosed Type 1 Diabetes,” it says.

Diamyd is described as an antigen-specific immunomodulatory therapeutic for preserving endogenous insulin production. It is designed to be administered directly into a superficial lymph node in children and young adults with recently diagnosed Type 1 Diabetes. “Injections into a superficial lymph node can be performed in minutes and are intended to optimize the treatment response,” the company says.