French pharmaceutical firm Ipsen (IPSEY) said Monday that the U.S. Food and Drug Administration or FDA has accepted and granted priority review of its supplemental New Drug Application or sNDA for Somatuline Depot 120mg injection in the treatment of gastroenteropancreatic neuroendocrine tumors or 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. Decision is expected in early first-quarter of 2015.
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 the second-quarter of 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.
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May 15, 2026 15:25 ET Apart from the confirmation of Kevin Warsh as the next Fed chair, the main news on the economics front this week included key price data from the U.S. and the first quarter economic growth figures from major economies. Both consumer prices and producer costs have started to reflect the effect of supply shocks due to the Middle East conflict. In Europe, GDP data was in focus, while inflation data from China dominated the news flow in Asia.