On September 1, 2014 Ipsen reported 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) (Press release Ipsen, SEP 1, 2014, View Source [SID:1234500724]). 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. Decision is expected in early Q1, 2015.

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In the European Union, the dossier of the national marketing authorization (MA) variations for Somatuline Autogel 120mg injection has been validated by all national 25 drug regulatory authorities. The first decisions are expected by Q2 2015.

The regulatory submissions and variations were supported by the results of the CLARINET Phase III study, which demonstrated the antitumor effect of Somatuline in the treatment of patients with GEP-NETs, and which was recently published in the July 17th issue of The New England Journal of Medicine.

Marc de Garidel, Chairman and Chief Executive Officer of Ipsen stated: "We are pleased that the US and European regulatory authorities have accepted the filing for Somatuline in the treatment of GEP-NETs and that the dossier in the US has been granted priority review. We are excited about the potential benefits Somatuline could bring to patients suffering from this debilitating disease".

The data from CLARINET is purely investigational, as Somatuline is not authorized for the indication of treatment of gastroenteropancreatic neuroendocrine tumors (GEP-NETs) in any market. In many countries where it is marketed as Somatuline Autogel, Somatuline is approved for treatment of acromegaly and for the symptoms associated with neuroendocrine tumors, which can include the treatment of GEP-NET patients experiencing symptoms from carcinoid syndrome, and Somatuline is approved in many countries for the treatment of acromegaly. Somatuline Depot is approved in the US for the treatment of acromegaly but not for the treatment of GEP-NETs or the symptoms thereof.