Diakonos Receives FDA Orphan Drug Designation
Diakonos announced today that it received Orphan Drug designation from the U.S. Food and Drug Administration (FDA) for malignant glioma, including treatment of newly diagnosed/refractory glioblastoma multiforme (GBM).
“Receiving the Orphan Drug Designation from the FDA is a valuable addition to our existing Fast Track Designation as it indicates that the cell therapy may be more broadly applicable to other oncological indications,” said Ian Bellayr, PhD, Chief Regulatory Officer of Diakonos, “As we continue to accumulate more safety and efficacy data with time, Diakonos will continue to leverage other FDA programs to expedite development.”
The FDA orphan drug designation provides seven years of marketing exclusivity along with other incentives such as tax credits, user fee waivers and federal grants to support clinical trials.
