Takeda Announces Positive Opinion from European Regulatory Authorities for Combination Use of Actos(R) with Insulin for Type 2 Diabetes.Tokyo, Japan, Dec 20, 2006 - (JCN Newswire) - Takeda Pharmaceutical Company Takeda Pharmaceutical Company Limited (武田薬品工業株式会社 Limited today announced that on December 14, 2006, its wholly owned subsidiary Wholly Owned Subsidiary A subsidiary whose parent company owns 100% of its common stock. Notes: In other words, the parent company owns the company outright and there are no minority owners. , Takeda Global Research & Development Centre (Europe), Ltd. ("TGRD Europe") received positive opinion from The Committee for Medicinal Products for Human Use “CHMP” redirects here. For French language Canadian radio station, see CHMP-FM. CPMP, Committee for Proprietary Medicinal Products, now CHMP Committee for Medicinal Products for Human Use ("CHMP") of the European Medicines Agency The European Medicines Agency (EMEA) is a European agency for the evaluation of medicinal products. Until 2004, the European Medicines Agency was known as The European Agency for the Evaluation of Medicinal Products. Roughly parallel to the U.S. ("EMEA"), recommending to grant the new indication for ACTOS(R) (pioglitazone HCl). The new indication is "combination with insulin in type 2 diabetes mellitus Type 2 diabetes mellitus One of the two major types of diabetes mellitus, characterized by late age of onset (30 years or older), insulin resistance, high levels of blood sugar, and little or no need for supple-mental insulin. patients with insufficient glycaemic control on insulin for whom metformin is inappropriate because of contraindications or intolerance." At the same time, the CHMP adopted the removal of the contraindication contraindication /con·tra·in·di·ca·tion/ (-in?di-ka´shun) any condition which renders a particular line of treatment improper or undesirable. con·tra·in·di·ca·tion n. for use of ACTOS in combination with insulin. Detailed conditions for the use of this product will be available after the variation to the marketing authorisation has been granted by the European Commission. "For the treatment of patients with type 2 diabetes type 2 diabetes n. See diabetes mellitus. , it is common that physicians need to use combinations of products in order to maintain glycaemic control over time", said Masaomi Miyamoto, Ph.D., General Manager of Pharmaceutical Development Division of Takeda. "The new indication for use of Actos in combination with insulin, once it is approved, will provide a further prescribing option for the physician, and help patients control their blood glucose effectively." Takeda is the originator of thiazolidinedione derivatives and ACTOS is a member of the thiazolidinedione class of "insulin-sensitizing" agents, and it directly targets insulin resistance. About Takeda Pharmaceutical Takeda Pharmaceutical, located in Osaka, Japan, is a research-based global company with its main focus on pharmaceuticals. As the largest pharmaceutical company in Japan and one of the global leaders of the industry, Takeda is committed to striving toward better health for individuals and progress in medicine by developing superior pharmaceutical products. Additional information about Takeda is available through its corporate website, http://www.takeda.com/index-e.html. Source: Takeda Pharmaceutical Contact: Takeda Pharmaceutical Shouji Wakayama Wakayama_Shouji@takeda.co.jp +81-6-6204-2111 Copyright [c] 2006 JCN Newswire. All rights reserved. A division of Japan Corporate News Network K.K. |
|
||||||||||||
Printer friendly
Cite/link
Email
Feedback
Reader Opinion