Ipsen files sNDA for Somatuline for GEP-NETs

French drugmaker Ipsen (Euronext: IPN) has submitted a Supplemental New Drug Application to the US Food and Drug Administration for Somatuline Depot 120mg (lanreotide) injection for the treatment of gastroenteropancreatic neuroendocrine tumors (GEP-NETs).

In the European Union, Ipsen has submitted national marketing authorization variations for Somatuline Autogel 120mg injection to the drug regulatory authorities in 25 countries of the European Union. Following EU and US submissions, Ipsen intends to implement worldwide submission roll-out. Regulatory submission is supported by the results of the CLARINET Phase III study, which demonstrated the antiproliferative effect of Somatuline in the treatment of patients with GEPNETs.

Marc de Garidel, chairman and chief executive of Ipsen, said: “There are significant unmet medical needs among GEP-NET patients and Ipsen is committed to help address them. The submission of supplemental marketing authorization applications in the USA and variations in Europe for Somatuline is evidence of our commitment to targeted oncology, and we are pleased to be able to submit them in our planned timeframe. ”