Ipsen's Somatuline Granted FDA Priority Review For Treatment Of GEP-NETs
By C. Rajan, contributing writer
Earlier this week, the U.S. FDA granted priority review to Ipsen's supplemental New Drug Application (sNDA) for Somatuline Depot 120mg injection for gastroenteropancreatic neuroendocrine tumors (GEP-NETs). The FDA's decision is expected in early 2015.
Ipsen has also filed for national marketing authorization (MA) variations for Somatuline Autogel 120mg injection with the European Union and has had its dossier accepted for review. The first decisions from Europe are expected by second quarter of 2015. Somatuline is marketed as Somatuline Depot within the United States and as Somatuline Autogel in other countries, including EU Member States.
Marc de Garidel, Chairman and CEO of Ipsen stated, “We are pleased that the U.S. 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”.
Somatuline (lanreotide acetate) was initially developed for the treatment of acromegaly, in which the circulating levels of growth hormone and/or Insulin-like Growth Factor-1 remain abnormal after surgery or radiotherapy. Somatuline is a somatostatin analogue that inhibits the secretion of several endocrine, exocrine, and paracrine amines and peptides, which are associated with acromegaly.
Somatuline is already approved in the U.S., Europe, and several other countries for the long-term treatment of acromegaly. Somatuline is not currently indicated as an antitumor agent for the treatment of GEP-NETs, and if Ipsen's submissions for GEP-NETs are approved, this will be the second major indication for Somatuline and could garner the company some decent profits. In 2011, the annual worldwide sales of Somatuline were over $250 million.
The regulatory submissions and variations for GEP-NETs were made on the basis of very positive results from the CLARINET Phase 3 study, which were published in The New England Journal of Medicine 2 in July. The data from the Phase 3 study showed that investigational treatment with Somatuline met the primary endpoints and substantially prolonged time to disease progression or death versus placebo, in 204 patients with GEP-NETs. The safety data was also consistent with the known safety profile of Somatuline.
GEP-NETs are rare but serious types of cancer found in the gastrointestinal tract and the pancreas. According to the WHO, their prevalence is about 35 per 100,000 persons worldwide, with about 1,000 cases diagnosed annually in the U.S. However, the incidence of GEP-NETs has increased almost 4 to 6 fold in the past thirty years. GEP-NETs can be clinically silent for long periods of time, which leads to a delayed diagnosis when late presentation of symptoms has begun and patients’ survival rates are lowered considerably.