Ipsen N.A., an affiliate of Ipsen, announced that the U.S. Food and Drug Administration (FDA) has accepted and granted priority review of its supplemental New Drug Application (sNDA) for Somatuline Depot 120mg injection in the treatment of gastroenteropancreatic neuroendocrine tumors (GEP-NETs). The FDA designates priority review status to drug candidates that have the potential to offer a significant improvement in treatment compared to currently approved options. A decision is expected in early Q1, 2015.
The regulatory submission was supported by the results of the investigational CLARINET Phase 3 study, which demonstrated the antitumor effect of Somatuline in the treatment of patients with GEP-NETs, and which was recently published in The New England Journal of Medicine.
Marc de Garidel, chairman and chief executive officer of Ipsen, said: “We are pleased that the U.S. regulatory authorities have accepted the filing for Somatuline in the treatment of GEP-NETs and that the dossier has been granted priority review. We are excited about the potential benefits Somatuline could bring to patients suffering from this debilitating disease.”
Cynthia Schwalm, president and CEO of Ipsen North America, added: “To date, somatostatin analogs are approved to manage symptoms of GEP NETs and are not approved as anti-tumor therapy. Somatuline is the first and only somatostatin analog to demonstrate a statistically significant improvement in progression free survival in GEP NET in a large, multinational study clinical trial.”
The data from CLARINET is investigational, as Somatuline Depot is not approved for the treatment of GEP-NETs. Somatuline Depot is currently approved in the US for the treatment of acromegaly.
Date: September 2, 2014