Ipsen and Teijin Pharma receive Japanese approval to extend indication of Somatuline.
M2 PHARMA-July 3, 2017-Ipsen and Teijin Pharma receive Japanese approval to extend indication of Somatuline
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The Japanese Ministry of Health, Labour and Welfare has given approval to Ipsen (EPA: IPN) and Teijin Pharma Ltd, the core company of Teijin Group's healthcare business, for Ipsen's subcutaneous drug Somatuline (lanreotide) to be indicated as a treatment for gastroenteropancreatic neuroendocrine tumours (GEP NET), the French company disclosed on Monday.
The drug is already approved for the treatment of acromegaly and pituitary gigantism in Japan since 2012.
Following Ipsen's investigational, pivotal Phase III randomised, placebo-controlled trial (CLARINET), which was conducted in 14 countries and involved 204 patients with GEP NET, as well as an open-label, single group, multicentre, Phase II trial conducted by Teijin Pharma in Japan, involving 32 patients with NET, the companies filed for additional approval in July 2016.
The approval makes Ipsen's drug the first available treatment in Japan for pancreatic NET.
Somatuline's active substance, lanreotide acetate, is a somatostatin analogue that inhibits the secretion of several endocrine, exocrine and paracrine functions. The drug is indicated for the treatment of acromegaly and neuroendocrine tumours in 70 countries.
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|Date:||Jul 3, 2017|
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