Radiopharmaceutical Receives Orphan Drug Designation


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The radiopharmaceutical gallium-68 dotatate has been given orphan drug designation by the U.S. Food and Drug Administration and the European Medicines Agency for use as a diagnostic agent for the management of gastroenteropancreatic neuroendocrine tumors (GEP-NETs).

Gallium-68 dotatate is owned by Advanced Accelerator Applications (AAA) and prepared using a kit patentted by AAA, which is reconstituted in hospital radiopharmacies without the use of a radiochemistry module.

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 has greater sensitivity and specificity for tumor detection than the current standard, and 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.” ■



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