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FDA 批准 ACTOplus met(R) XR 片剂用于治疗2型糖尿病 美通社-PR Newswire5月13日伊利诺伊州迪尔菲尔德和日本大阪电 Takeda Pharmaceutical Company Limited 及其全资子公司 Takeda Pharmaceuticals North America, Inc. 今天宣布，美国食品和药物管理局 (U.S. Food and Drug Administration, FDA) 已批准将缓释型组合药物 ACTOplus met(R)（盐酸匹格列酮 (pioglitazone HCl) 和盐酸二甲双胍 (metformin HCl)）作为治疗2型糖尿病的一种饮食和锻炼辅助剂。ACTOplus met(R) XR 是首款也是唯一一款带有二甲双胍缓释剂的抗糖尿病固定剂量口服组合药物，旨在通过每天一次的方便的剂量选择帮助改善血糖控制。ACTOplus met XR 用于对已经采用 ACTOS(R)（盐酸匹格列酮）和二甲双胍治疗的进行治疗，或者单独采用 ACTOS 或二甲双胍治疗而不足以控制血糖的2型糖尿病成年患者。
LINCOLNSHIRE, Ill., August 29, 2005 ?Takeda Pharmaceuticals North America, Inc. (TPNA) today announced that the U.S. Food and Drug Administration (FDA) has approved the New Drug Application (NDA) for ACTOplus metTM for the treatment of type 2 diabetes. This is the second Takeda product approved in the U.S. this summer, following the approval of ROZEREMTM (ramelteon) on July 22, 2005. To offer physicians greater flexibility in treating their patient's needs, ACTOplus met will be available in two dosages of pioglitazone/metformin ?15 mg/500 mg and 15 mg/850 mg ?both of which are to be given once a day or in divided doses not exceeding the maximum recommended daily doses of pioglitazone 45 mg and metformin 2,550 mg as mentioned in the approved labeling. "To reach target blood glucose levels, many people with type 2 diabetes will have to take a combination of therapies. In fact, within three years of being prescribed their first medication, approximately 50 percent of patients will need to add additional therapies to manage their condition," said Ralph DeFronzo, M.D., professor of Medicine and chief of the Diabetes Division at the University of Texas Health Science Center at San Antonio. "ACTOplus met may help patients reduce the number of pills they take each day, and offers a new and convenient treatment option." According to the American Diabetes Association, diabetes affects more than 18 million people, and type 2 diabetes is the most common form of the disease. Both ACTOS and metformin are widely used medications in the treatment of type 2 diabetes and both have a known safety profile. Combining these medications may provide patients with an easier way to take the two drugs, as they are already often prescribed together to help manage the disease. Takeda Global Research & Development Center, Inc. submitted the ACTOplus met NDA in October 2004. Takeda expects the medication to be available to patients by October 2005. "Takeda is committed to developing appropriate treatment options for healthcare providers and their patients," said Mark Booth, president of Takeda Pharmaceuticals North America, Inc. "ACTOplus met reflects that commitment by offering a convenient option for people with type 2 diabetes and an important new addition to the ACTOS portfolio." |
