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 designation is intended to bring promising medicines to patients sooner.
“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”, says Ulf Hannelius, CEO of Diamyd Medical. “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.”
For further information regarding Fast Track drug development programs, please refer to the Guidance for Industry: Expedited Programs for Serious Conditions – Drugs and Biologics at http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM358301.pdf
Staging of Type 1 Diabetes – Opportunity for Prevention and Early Intervention
Type 1 Diabetes (T1D) is a chronic autoimmune disease that attacks the insulin producing beta cells in the pancreas. The onset of T1D starts months to years before symptomatic disease and is divided into disease stages. Individuals 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. Individuals with Stage 2 T1D have progressed to abnormal blood glucose values (so-called dysglycemia) but are otherwise asymptomatic. Stage 3 T1D is synonymous with clinically diagnosed Type 1 Diabetes.
Diamyd Medical develops treatments for all stages of T1D. The target population for the DiaPrecise trial comprises individuals with Stages 1 T1D or Stage 2 T1D, whilst individuals with Stage 3 T1D (i.e. clinically diagnosed T1D) are the target population for the pivotal Phase III trial DIAGNODE-3 with the antigen-specific immunotherapy Diamyd®.
