Candel Therapeutics Receives Orphan Drug Designation from the European Medicines Agency for CAN-2409 in Glioma
Retrieved on:
Thursday, September 15, 2022
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The orphan drug designation follows the U.S. Food and Drug Administration (FDA) fast track designation, which was granted in June 2021, for CAN-2409 in combination with valacyclovir following standard of care treatment in newly diagnosed high-grade glioma.
Key Points:
- The orphan drug designation follows the U.S. Food and Drug Administration (FDA) fast track designation, which was granted in June 2021, for CAN-2409 in combination with valacyclovir following standard of care treatment in newly diagnosed high-grade glioma.
- Paul Peter Tak, MD, PhD, FMedSci, President and CEO of Candel, said, "Glioma, while mercifully rare, is a devastating disease with significant morbidity and mortality.
- The EMA's orphan drug designation recognizes the high unmet need and the potential of CAN-2409 in this patient population.
- Orphan drug designation in the European Union (EU) is granted by the European Commission based on a positive opinion issued by the EMA COMP.