ARTICLE | Clinical News

Somatuline Depot regulatory update

September 8, 2014 7:00 AM UTC

Ipsen said FDA accepted and granted Priority Review to an sNDA to expand the label of lanreotide to include treatment of gastroenteropancreatic neuroendocrine tumors (GEP-NETs). Additionally, Ipsen said regulatory applications for lanreotide have been accepted by all 25 national regulatory authorities in the EU. Ipsen expects a decision in 1Q15 in the U.S. and in 2Q15 in Europe.

Ipsen already markets the extended-release formulation of somatostatin analog lanreotide as Somatuline Depot in the U.S. to treat acromegaly and in the EU as Somatuline Autogel to treat acromegaly and neuroendocrine tumors. ...