AAA today announced that the European Medicines Agency (EMA) has issued a positive opinion on the Marketing Authorization Application for SomaKit TOC 40µg, 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.
Following approval by the EC, SomaKit TOC will be made available to the European market as soon as possible. In most European countries, SomaKit TOC will be available as a unique kit for reconstitution, including two vials and a cartridge for direct elution using a gallium Ga 68 generator.
“We are excited to have achieved a positive EMA opinion on our SomaKit TOC application,” said Stefano Buono, Chief Executive Officer of AAA. “This milestone comes soon after U.S. Food and Drug Administration (FDA) approval of NETSPOT™ (gallium Ga 68 dotatate) in June. We believe our diagnostic products offer NET patients superior accuracy and specificity compared to previously available diagnostic products, while reducing patient burden.”
“AAA is committed to bringing innovation to NET patients,” added Buono. “Between NETSPOT™, SomaKit TOC, and our therapeutic product, Lutathera, our team has simultaneously managed four major regulatory submissions to the FDA and EMA for this indication over the course of this year.«