Diamyd Medical receives second U.S. FDA Fast Track designation for Diamyd® - for the prevention of Type 1 Diabetes
Diamyd Medical announced today that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for Diamyd[®] (rhGAD65/alum) to treat 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[®] received Fast Track designation for the treatment of individuals with Stage 3 Type 1 Diabetes carrying the HLA DR3-DQ2 genotype. The FDA grants Fast Track designation to facilitate the development and expedite the review of medicines to treat serious conditions and fill an unmet medical need. Fast Track