US FDA grants orphan drug status to EnGeneIC’s EGFR-targeted
EnGeneIC Ltd., a clinical stage biopharmaceutical company, has announced that US Food and Drug Administration (FDA) has granted Orphan Drug Designation to EGFR-targeted, doxorubicin-loaded EDV nanocells for the treatment of glioblastoma multiforme (GBM).
Jennifer MacDiarmid, Ph.D., joint-chief executive officer and director of EnGeneIC, commented, “We are pleased that the FDA has granted Orphan Drug Designation to our targeted EDV nanocells for the treatment of GBM, a difficult-to-treat cancer indication with an especially poor prognosis. This is not only an important US regulatory milestone, but an exciting step towards our US clinical advancement.”
Orphan Drug Designation is granted by the FDA Office of Orphan Products Development (OOPD) to novel drugs or biologics that treat a rare disease or condition affecting fewer than 200,000 patients in the US. The designation provides the drug developer with a seven-year period of US marketing exclusivity, as well as tax credits for clinical research costs, the ability to apply for annual grant funding, clinical research trial design assistance and waiver of Prescription Drug User Fee Act (PDUFA) filing fees.