Advanced Accelerator Applications Announces Revised EMA Review Timeline for Lutathera®

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).

Our team is working closely with EMA reviewers to facilitate this process,” said Stefano Buono, Chief Executive Officer of AAA. “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. I am pleased to share that in the last month, the U.S. Food and Drug Administration has successfully completed inspections of both of our CROs, several clinical sites and all of our manufacturing sites.