The request for the additional approval was filed in July 2016, based on Ipsen’s investigational, pivotal phase III randomised placebo-controlled trial (CLARINET) in 204 patients with gastroenteropancreatic neuroendocrine tumours (GEP NET) conducted in 14 countries, and an open-label single group multicenter Phase II trial (J-001) in 32 patients with NET that Teijin Pharma conducted in Japan.
This approval establishes Somatuline as the first drug available in Japan for the treatment of pancreatic NET.
Harout Semerjian, Executive Vice-President & President, Specialty Care International & Global Franchises, said: "We are pleased that Somatuline is now also available for Japanese patients suffering from gastrointestinal and pancreatic neuroendocrine tumours. In line with our commitment to serve NET patients worldwide, this is a significant step after our partner Teijin launched Somatuline for the treatment of acromegaly and pituitary gigantism in Japan in January 2013.”
NETs are malignant tumours arising from neuroendocrine cells. Most of the NET tumours present with metastasis and are discovered fortuitously. In some patients, excess hormones secreted from a NET can lead to severe diarrhoea, peptic ulcers or hypoglycaemia.
While incidence rates are relatively rare, at about 3.5 gastrointestinal NET patients and 1.3 pancreatic NET patients per 100000 people in Japan, the number of patients has been increasing year by year due to disease awareness and better diagnosis Tetsuhide Ito et al. J Gastroenterol (2015).
Akihisa Nabeshima, President of Teijin Pharma, said: "It is our great pleasure to now have the capacity to provide a new therapeutic option to NET patients in Japan. We will continue to focus on drug discovery and improve the quality of life of patients by offering them new treatment options to fulfill unmet medical needs.”
The primary treatment for NETs is removal by surgery, but if this is not possible as the disease is usually disseminated, or if a tumour relapses following surgery, another option is a medical treatment.
The active substance in Somatuline is lanreotide acetate, a somatostatin analogue inhibiting the secretion of several endocrine, exocrine and paracrine functions.
It has been shown to be effective in inhibiting the secretion of GH and certain hormones secreted by the digestive system. Somatuline is marketed as Somatuline Depot within the US and as Somatuline Autogel in other countries where it has marketing authorisation. Somatuline is indicated for the treatment of acromegaly and neuroendocrine tumours in 70 countries.
