Gallium-68 DOTATATE has received orphan drug designation status, 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).
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.
The EMA’s orphan medicinal product designation is designed to promote the development of drugs that may provide significant benefit to patients suffering from rare, life-threatening diseases. In addition to ten years of market exclusivity, the orphan drug designation also provides special incentives for sponsors including eligibility for protocol assistance and possible exemptions or reductions in certain regulatory fees during development or at the time of application for marketing approval. Similarly, FDA orphan drug designation is intended to encourage companies to develop therapies for the treatment of diseases that affect fewer than 200,000 individuals in the U.S.