日本剛核准Oblean (cetilistat) tablets 120mg

熱門話題－威力纖plus所含禁藥 中藥材亦有 中國時報 高資敏／中華醫療科技協會理事長 2013年10月31日 04:10 立法委員李應元揭發連惠心代言的「威力纖plus」，檢驗出「禁藥」cetilistat（大陸音譯為新利司他），掀起連串風波。Cetilistat蘊藏於諸多藥用及食用植物，如紅參、葛根、蘆丁、刺蒺、大豆蛋白、蕃茄紅等。中國生產cetilistat的生技廠，泰半自此等當地植物萃取。Cetilistat最先由英國Alzyme藥廠研究發現，確定是很有效lipase inhibitor，可緩止腸胃吸收脂肪，有減肥特效。之後，Alzyme與日本武田製藥株式會社合作，於2003年開始1期、隨後2期臨床試驗，在2008年進入3期階段，於2012年完成，正式向日本厚生省提出新藥申請，並已獲日本准許上市。武田於今年9月20日對外宣布新藥名Oblean (化學名為cetilistat)。Cetilistat的藥效早已明確建立。臨床也證明副作用甚小，主要是腸胃方面，因服藥中脂肪不易消化，而釀成含大量油質的糞便，有時會導致大便失控。美國尚未核准該藥，部分是因關注器官移植的病患。該藥可能會使原服用的「抗器官排斥藥」失效，而導致植入的器官被排斥。「威力纖plus」事件中，嚴加指責的一方，最關鍵的責難是「威力纖plus」中檢驗出含有「西藥」cetilistat，故已犯我國《藥事法》。然而，在許多植物，包括多種中藥材，都含有此一化學物質。我國的本草綱木違反了《藥事法》？神農侵犯了「西藥」？cetilistat經國際合作長期研究，已確證有助治療肥胖症，減少心血管疾病。良藥當然應盡早嘉惠於國人。

Norgine and Takeda announce the new drug application approval of Oblean (cetilistat) tablets 120mg in Japan Tuesday 24 September 2013 - 2am PST Norgine and Takeda announce the new drug application approval of Oblean (cetilistat) tablets 120mg in Japan Norgine and Takeda Pharmaceutical Company Limited has announced that the Japanese Ministry of Health, Labour and Welfare has approved the New Drug Application (NDA) of OBLEAN Tablets 120mg for the treatment of obesity with complications. OBLEAN is a lipase inhibitor discovered by UK-based Alizyme Therapeutics Limited. Norgine acquired all rights to the product from Alizyme in October 2009. In 2003 Takeda acquired the rights for development and commercialisation for Japan. OBLEAN inhibits the activity of lipase, a lipolytic enzyme, secreted by the digestive tract and pancreas, and blocks the absorption of fat from the gut, resulting in not only reduced body weight, but also reduced visceral fat and improved parameters related to lifestyle diseases. OBLEAN is the first therapy that controls lipid absorption approved in Japan for the treatment of obesity with complications. The NDA submission is based on the results of three phase 3 clinical trials in obese patients with type 2 diabetes and dyslipidemia: a 52-week placebo-controlled, double-blind study to evaluate the efficacy and safety, and two open-label studies to evaluate safety, 24-week and 52-week respectively. The results of the 52-week placebo-controlled, double-blind study demonstrate that OBLEAN 120mg three times daily is superior to placebo in the primary endpoint, with a mean reduction in body weight from baseline of -2.776% with OBLEAN versus -1.103% with placebo (p=0.0020).[1] Greater reductions in HbA1c and low-density lipoprotein cholesterol were also observed in patients treated with OBLEAN[1], compared to placebo. In all these three studies, OBLEAN showed a good safety profile and was well tolerated. [1, 2, 3] In filing for this approval, Takeda utilised the Preliminary Assessment of the Pharmaceuticals and Medical Devices Agency (PMDA).* Paul Pay, VP Corporate and Business Development at Norgine said; "Being overweight or obese is a major risk factor in the development of many chronic diseases and we are pleased that Takeda has obtained manufacturing and marketing approval by the regulatory authorities in Japan." "Obesity is an increasingly important issue in Japan with limited treatment options" said Nancy Joseph-Ridge M.D., General Manager of Takeda's Pharmaceutical Development Division. "The approval of OBLEAN, with its novel mechanism of action, provides options for this unmet medical need to patients with obesity, with complications of both type 2 diabetes and dyslipidaemia in Japan."

Type 2 Diabetes Type 2 diabetes develops when the body can't produce enough insulin, or when the insulin that is produced doesn't work properly. If untreated, it can cause very serious health problems.

HbA1c HbA1c is a term often used in relation to diabetes. HbA1c occurs when haemoglobin joins with glucose in the blood. Haemoglobin molecules make up the red blood cells in the blood stream. When glucose sticks to these molecules it forms a glycosylated haemoglobin molecule, also known as A1c and HbA1c. The more glucose found in the blood the more glycated haemoglobin (HbA1c) will be present.

Low-density lipoprotein (LDL) cholesterol LDL collects in the walls of blood vessels, causing the blockages of atherosclerosis. Higher LDL levels put people at greater risk for a heart attack from a sudden blood clot in an artery narrowed by atherosclerosis.

Dosage and Administration Usually, for adults, a dose of 120 mg is orally administered, three times a day, immediately after each meal.

Indication Obesity (limited to patients with both type 2 diabetes mellitus and dyslipidemia, and with a BMI≥25 kg/m2 in spite of dietary treatment and/or exercise therapy)