Diamyd Medical receives orphan drug designation
NEW YORK The Food and Drug Administration has given orphan drug designation to a vaccine for Type 1 diabetes made by Diamyd Medical, the Swedish drug maker announced Wednesday.
The designation was given to rhGAD65, a drug in late-stage development for Type 1 diabetes with residual beta cell function. The FDA grants orphan drug designation to therapies for diseases that affect fewer than 200,000 Americans. The designation includes seven years’ market exclusivity rather than the customary five, funding for clinical studies, clinical design assistance and financial benefits such as FDA user fee waivers and tax credits.
The drug is undergoing a phase 3 clinical trial testing whether it can slow the destruction of insulin-producing beta cells, thus preserving the body’s ability to control blood sugar levels. The trial is still enrolling patients.