The kit has been designated as an orphan drug by the EMA and the FDA.Īdvanced Accelerator Applications (AAA) is an innovative radiopharmaceutical company that develops, produces and commercializes Molecular Nuclear Medicine (MNM) products. NETSPOT TM is a novel patented kit developed by AAA for the preparation of gallium Ga 68 dotatate for injection, for localization of somatostatin receptor positive neuroendocrine tumors (NETs) in adult and pediatric patients using Positron Emission Tomography (“PET“). In the European Union, orphan drugs are defined as drugs that treat diseases or conditions that affect fewer than five out of 10,000 individuals in the European Union.
In the United States, orphan drugs are defined as drugs that treat diseases or conditions that affect 200,000 or fewer individuals in the country. regulatory authorities, meaning that they affect a relatively small population of individuals in the relevant jurisdiction. NETs are classified as orphan diseases by European and U.S. The estimated incidence of NETs for the combined populations of the United States and the European Union is approximately 47,300. These cancers are rare but they are the second most common type of gastrointestinal malignancy and their incidence is increasing. NETs can remain clinically silent for years delaying the diagnosis in a large number of patients. Neuro Endocrine Tumors, also known as NETs, are a group of tumors originating in the neuroendocrine cells of many different organs. 1 Even though NETs have historically been considered as rare tumors (orphan disease) their incidence has grown over 500% over the last 3 decades. The estimated incidence of NETs for the combined populations of the United States and the European Union is approximately 47,300 patients/year. We believe that the use of NETSPOT TM should also offer increased comfort for patients by potentially shortening a procedure that is currently performed over 24 hours or more to just a few hours.” “ NETSPOT TM has the potential to significantly improve the accuracy of NET diagnosis, while reducing radiation exposure for patients. “The FDA approval of NETSPOT TM is a key milestone in our mission of improving the lives of NET patients,” said Stefano Buono, Chief Executive Officer of AAA.
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NETSPOT TM is currently approved for use with the GalliaPharm Ga 68 generator from Eckert & Ziegler. AAA intends to commercialize the product in the US in two forms: As a kit for reconstitution using a Ga 68 generator, and as NETSPOT TM Injection, a ready-to-use dose delivered from a local radiopharmacy in selected metropolitan areas.
Gallium Ga 68 dotatate received Orphan Drug Designation from both the FDA and European Medicines Agency (EMA) in March 2014.įollowing today’s approval, NETSPOT TM will be made available to the US market as soon as possible. NETSPOT TM is the first approved drug using Ga 68 as a positron emitter. NETSPOT TM is the new market name for Somakit-TATE (a kit for the preparation of gallium Ga 68 dotatate injection) in the US. NETSPOT TM received approval following a Priority Review from the FDA. (NASDAQ:AAAP) (“AAA” or “the Company”), an international specialist in molecular nuclear medicine, today announced that the US Food and Drug Administration (FDA) has approved NETSPOT TM (Somakit-TATE) for the localization of somatostatin receptor positive neuroendocrine tumors (NETs) in adult and pediatric patients. Radionuclide is not supplied with the kit.SAINT-GENIS-POUILLY, France, J(GLOBE NEWSWIRE) - Advanced Accelerator Applications S.A.
Approved Use: indicated for use with PET imaging for localization of somatostatin receptor positive neuroendocrine tumors (NETs) in adult and pediatric patients
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