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news.French pharmaceutical company Ipsen has filed a supplemental new drug application (sNDA) with the US Food and Drug Administration (FDA) for approval of its Somatuline Depot 120mg injection to treat gastroenteropancreatic neuroendocrine tumours (GEP-NETs).
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The company has submitted national marketing authorization variations for Somatuline Autogel 120mg injection to the drug regulatory authorities in 25 countries of the EU.
Upon submissions in EU and US, the company intends to implement worldwide submission roll-out.
The sNDA filing is based on positive data from the CLARINET Phase III trial of Somatuline in treating patients with GEP-NETs.
The Phase III trial has showed the antiproliferative effect of Somatuline in treatment of GEP-NETs patients.
According to the company, data from the CLARINET demonstrated that investigational treatment with Somatuline substantially prolonged time to disease progression or death versus placebo.
The safety data generated from the trial were consistent with the known safety profile of Somatuline.
Ipsen chairman and CEO Marc de Garidel said, "The submission of supplemental marketing authorisation applications in the US 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."