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Advanced Accelerator Applications (AAA), a fast growing international player in Molecular Nuclear Medicine (MNM), announced today 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 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.
Existing data show that the Gallium-68-labeled PET radiopharmaceutical should represent a major improvement compared to the current standard. 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.
Stefano Buono, Chief Executive Officer of AAA, commented: “GEP-NETs constitute a life-threatening disease and effective patient management requires accurate diagnostic tools. The orphan drug designation of AAA‘s Gallium-68 DOTATATE will accelerate the development of this agent and hopefully allow it to be available to patients in the next few years.“