FDA Grants Diamyd Medical´s Diamyd Orphan Drug Designation


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.

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