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Diamyd Medical receives FDA Fast Track designation

The U.S. Food and Drug Administration (FDA) has granted Fast Track designation for Diamyd that is being investigated to improve glycemic control in recently diagnosed stage 3 Type 1 Diabetes patients with the genotype HLA DR3-DQ2.

“We are very pleased with the FDA’s decision to grant Fast Track designation for Diamyd and the potential this provides to accelerate Diamyd’s path to entering the US market,” says Ulf Hannelius, CEO of Diamyd Medical. “Type 1 diabetes is a progressive, chronic and irreversible autoimmune disease that affects millions of patients worldwide. Diamyd, currently evaluated in the first ever precision medicine Phase 3 trial in type 1 diabetes, DIAGNODE-3, represents a significant shift towards personalized medicine in the treatment of type 1 diabetes. This offers new hope beyond the traditional insulin therapy, emphasizing our dedication to advancing care and improving outcomes for patients.”


The confirmatory Phase III trial DIAGNODE-3, evaluating the safety and efficacy of the antigen-specific immunotherapy Diamyd in individuals diagnosed with Type 1 Diabetes is ongoing in the United States and in eight European countries: Sweden, Spain, the Czech Republic, the Netherlands, Germany, Poland, Hungary and Estonia.


DIAGNODE-3 will enroll up to 330 individuals aged 12 to 29 years, recently diagnosed (within 6 months) with Type 1 Diabetes, who carry the HLA DR3-DQ2 haplotype, a certain genetic risk factor for Type 1 Diabetes. A further stratification for HLA haplotypes is included in order to evaluate the potential super responder group of individuals who are positive for HLA DR3-DQ2 and negative for HLA DR4-DQ8. HLA testing is well established and widely available.

This patient population is based on clinical efficacy and safety results from the Phase IIa and Phase IIb trials DIAGNODE-1 and DIAGNODE-2, as well as on the large-scale meta-analysis encompassing data from more than 600 individuals from previous Phase II and Phase III trials using Diamyd. The trial design provides a high probability to reach its co-primary endpoints of preservation of endogenous insulin producing capacity measured as stimulated C-peptide and improved blood glucose control as determined by HbA1c.

Photo of Ulf Hannelius: Diamyd/Umeå Biotech Incubator