AAA Receives Orphan Drug Designation for Gallium-68 DOTATATE

Advanced Accelerator Applications (AAA) announced that it has 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 is a radiopharmaceutical used in PET/CT imaging of GEP-NETs. The product 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.

Available data indicates that Gallium-68 DOTATATE not only has greater sensitivity and specificity for tumor detection than the current standard, but it is also expected to significantly reduce radiation doses received by patients.

Source: Drug Discovery and Development Magazine