![]() “ 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.„ Advanced Accelerator Applications Announces Two Phase II Studies Evaluating 99MTc-rhAnnexin V-128 Imaging in Cardiovascular and Cardio-Oncology Indications at University of Ottawa Heart Institute and Ottawa HospitalĪAA today announced the initiation of two Phase II clinical studies evaluating 99MTc-rhAnnexin V-128 (Annexin), a single-photon emission computed tomography (SPECT) diagnostic candidate for the assessment of apoptosis and necrosis, forms of cell death in cardiovascular and cardio-oncology indications at the University of Ottawa Heart Institute and The Ottawa Hospital. “ AAA is committed to bringing innovation to NET patients,” added Buono. We believe our diagnostic products offer NET patients superior accuracy and specificity compared to previously available diagnostic products, while reducing patient burden.” ![]() Food and Drug Administration (FDA) approval of NETSPOT™ (gallium Ga 68 dotatate) in June. “ We are excited to have achieved a positive EMA opinion on our SomaKit TOC application,” said Stefano Buono, Chief Executive Officer of AAA. 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. The European Commission (EC) decision regarding granting of marketing authorization in all EU countries is expected in the coming months.įollowing approval by the EC, SomaKit TOC will be made available to the European market as soon as possible. Food and Drug Administration has successfully completed inspections of both of our CROs, several clinical sites and all of our manufacturing sites.” Advanced Accelerator Applications Announces Positive EMA Opinion on Application for SomaKit TOC Kit for Radiopharmaceutical Preparation of Gallium (Ga 68) Edotreotide for Gastroenteropancreatic Neuroendocrine Tumor DetectionĪAA 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. ![]() I am pleased to share that in the last month, the U.S. “ While the time required to address these requests and conduct the work with the involved CRO will prevent the achievement of the original Accelerated Assessment timeline, the EMA’s revised approval timeline continues to be in line with what we have anticipated for our commercial planning in Europe. “ Our team is working closely with EMA reviewers to facilitate this process,” said Stefano Buono, Chief Executive Officer of AAA. AAA today announced that the Accelerated Assessment timeline for the European Medicines Agency (EMA) review of the Marketing Authorization Application (MAA) for Lutathera®, a Lu-177-labeled somatostatin analogue peptide currently under development for the treatment of neuroendocrine tumors (NETs), has been modified to a standard review period due to additional clarifications requested by the EMA, as well as their request to inspect one of AAA’s contract research organizations (CRO). ![]()
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