Diamyd Medical announced the Food and Drug Administration (FDA) granted its type 1 diabetes drug candidate Diamyd® Orphan Drug Designation.
Orphan drugs qualify for several incentives including a seven-year period of market exclusivity in the US.
Diamyd is conducting a global Phase III clinical program to investigate whether Diamyd® can halt or slow the autoimmune destruction of insulin producing beta cells in type 1 diabetes, preserving the body’s own ability to control blood sugar levels. The US study, DiaPrevent, is still enrolling patients.
Diamyd® has been shown, in Phase II studies, to preserve the remaining beta cell function in children and adolescents recently diagnosed with type 1 diabetes.