Somatuline Autogel submitted to EMA for Neuroendocrine Tumors-Ipsen
Ipsen has submitted national marketing authorization variations for Somatuline Autogel 120mg injection to the drug regulatory authorities in 25 countries for the treatment of GastroEnteroPancreatic Neuroendocrine Tumors (GEP-NETs). 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 GEP-NETs.
The data from CLARINET showed that investigational treatment with Somatuline substantially prolonged time to disease progression or death versus placebo. Safety data generated from the CLARINET study were consistent with the known safety profile of Somatuline. Somatuline is not authorized for the indication of antiproliferative treatment of GEP-NETs in any market.
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