Advanced Accelerator Applications announces that they have received orphan drug designation status for their radiopharmaceutical, Gallium-68 DOTATATE. The orphan drug designation has been granted by both the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) for use of Gallium-68 DOTATATE as a diagnostic agent for the management of Gastro-Entero-Pancreatic Neuroendocrine Tumors (GEP-NETs). The designation should foster rapid development of the agent for the benefit of GEP-NET patients in the U.S. and Europe.
Gallium-68 DOTATATE will be prepared using AAA’s patented kit, which is reconstituted in hospital radiopharmacies without the use of a radiochemistry module, thus making the product available to all hospitals, even those who do not have a fully equipped GMP production radiopharmacy unit.