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 for treatment of gastroenteropancreatic neuroendocrine tumours (GEP-NETs).
The company has submitted national marketing authorisation variations for Somatuline Autogel 120mg injection to the drug regulatory authorities in 25 countries of the EU.
Ipsen is planning to implement worldwide submission roll-out following EU and US submissions.
The submission is based on positive data from the CLARINET Phase III study of Somatuline in treating patients with GEP-NETs.
The Phase III study has demonstrated the antiproliferative effect of Somatuline in treatment of GEP-NETs patients.
According to Ipsen, data from the CLARINET showed that investigational treatment with Somatuline substantially prolonged time to disease progression or death versus placebo.
Safety data generated from the study 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.”
The active substance in Somatuline [(Somatuline Autogel / Somatuline Depot) (lanreotide) injection 120mg is lanreotide acetate.
Lanreotide acetate is a somatostatin analogue that inhibits the secretion of several endocrine, exocrine and paracrine functions.
Somatuline is marketed as Somatuline Depot within the US and as Somatuline Autogel in other countries where it has marketing authorisation, including various EU member states.
Image: Micrograph of a neuroendocrine tumour, hematoxylin and eosin stain. Photo: courtesy of Nephron.