Ipsen (EPA:IPN) said today that Teijin Pharma Ltd. won approval from the Japanese Ministry of Health, Labor and Welfare for Ipsen’s Somatuline as a therapy for gastroenteropancreatic neuroendocrine tumors.
The subcutaneous drug was approved in Japan in 2012 for the treatment of acromegaly and pituitary gigantism.
The latest approval was supported by Ipsen’s pivotal Phase III trial which enrolled 204 patients with gastroenteropancreatic neuroendocrine tumors, as well as a 32-patient Phase II trial conducted by Teijin Pharma.
Somatuline is the 1st drug available in Japan as a therapy for pancreatic neuroendocrine tumors, according to Ipsen.
“We are pleased that Somatuline is now also available for Japanese patients suffering from gastrointestinal and pancreatic neuroendocrine tumors,” Harout Semerjian, exec VP and president of Ipsen’s specialty care international and global franchises, said in prepared remarks. “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.”
“It is our great pleasure to now have the capacity to provide a new therapeutic option to NET patients in Japan,” Akihisa Nabeshima, Teijin Pharma’s president, added. “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.”