Advanced Accelerator Applications (AAAP) Receives Positive EMA Opinion on SomaKit TOC MAA
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Advanced Accelerator Applications S.A. (Nasdaq: AAAP) announced that the European Medicines Agency (EMA) has issued a positive opinion on the Marketing Authorization Application for SomaKit TOC 40 µg, a kit for radiopharmaceutical preparation of gallium (Ga 68) edotreotide solution for injection, for Positron Emission Tomography (PET) imaging of somatostatin receptor overexpression in adult patients with confirmed or suspected well-differentiated gastroenteropancreatic neuroendocrine tumors (GEP-NET) for localizing primary tumors and their metastases.
The European Commission (EC) decision regarding granting of marketing authorization in all EU countries is expected in the coming months. Once marketing authorization is granted, SomaKit TOC will benefit from 10-year orphan market exclusivity in the European territory.
“We believe our diagnostic products offer significant benefits to NET patients, including enhanced accuracy and specificity, while alleviating patient burden,” said Stefano Buono, Chief Executive Officer of AAA. “We look forward to making SomaKit TOC available to the European market following approval by the EC.”
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