This designation aims to expedite the development and review of the therapy for paediatric patients with early-stage type 1 diabetes carrying the HLA DR3-DQ2 genotype.
The status aids in the development and speeding up of the review processes of medicines for treating various serious conditions and filling an unmet medical need.
Diamyd, which targets the preservation of insulin production, is now recognised for its potential to address an unmet medical need in both the early and later stages of type 1 diabetes.
Diamyd Medical focuses on precision medicine therapies across all stages of type 1 diabetes.
The company’s DiaPrecise trial is currently targeting individuals with Stage I or II type 1 diabetes, while the DIAGNODE-3 Phase III trial is enrolling patients with newly diagnosed Stage III type 1 diabetes.
Diamyd has previously demonstrated significant results in preserving insulin production in a genetically predefined patient group.
Diamyd Medical is also developing Remygen, a GABA-based drug for metabolic diseases, and is a major shareholder in NextCell Pharma and MainlyAI.
With a biomanufacturing facility underway in Umeå, Sweden, Diamyd Medical is poised to produce the active ingredient in Diamyd and advance the treatment of diabetes on multiple fronts.
Diamyd Medical CEO Ulf Hannelius said: “We are thrilled to receive our second fast track designation for Diamyd, this time for its potential to delay the onset of clinically diagnosed type 1 diabetes.
“This recognition once again underscores the potential of our precision medicine approach and the urgent need for new treatment options for type 1 diabetes across the disease spectrum. We now have the opportunity to work closely with the FDA to accelerate the development of Diamyd also as a preventive medicine.”