The active substance in Somatuline is lanreotide acetate, a somatostatin analogue that inhibits the secretion of several endocrine, exocrine and paracrine amines and peptides.
Decision from the FDA on the sNDA of Somatuline Depot injection is expected in the first quarter of 2015.
FDA priority review status is given to drug candidates that have the potential to provide a significant improvement in treatment compared to the currently approved options.
In the EU, all 25 national drug regulatory authorities have validated the dossier of the national marketing authorization (MA) variations for Somatuline Autogel 120mg injection.
The submissions are based on results of the CLARINET Phase III trial, which showed the antitumor effect of Somatuline in the treatment of patients with GEP-NETs.
Ipsen chairman and chief executive officer Marc de Garidel said the company is happy that the US and European regulatory authorities have accepted the filing for Somatuline in the treatment of GEP-NETs and that the dossier in the US has been granted priority review.
"We are excited about the potential benefits Somatuline could bring to patients suffering from this debilitating disease," Garidel said.
In the US, Somatuline is marketed as Somatuline Depot, and in other countries where it has marketing authorization, including various EU Member States, it is marketed as Somatuline Autogel.