Swedish clinical-stage diabetes company Diamyd Medical AB (STO:DMYD-B) announced on Thursday that it has received Fast Track designation from the US Food and Drug Administration (FDA) for Diamyd (rhGAD65/alum) intended for the treatment of type 1 diabetes in paediatric patients with Stage 1 or Stage 2 type 1 diabetes carrying the genotype HLA DR3-DQ2.
Earlier this year, the company received Fast Track designation for the treatment of individuals with Stage 3 type 1 diabetes carrying the HLA DR3-DQ2 genotype.
Ulf Hannelius, Diamyd Medical CEO, 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."
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