药品信息:
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药名:Edarbi (阿齐沙坦酯azilsartan medoxomil)
适应症:高血压
公司:武田制药(Takeda Pharmaceutical)
类型:小分子药物
简介:Edarbi是每日一次的口服高血压药物。在Edarbi获得FDA批准后,去年冬天,武田制药又一次从FDA获得了好消息。FDA称,研究显示,该药物相对于诺华的代文(Diovan)和第一三共的Benicar,疗效更好。最近,该药在日本和欧洲也获得了批准。在日本以Azilva的商品名出售。
中文名称: 阿齐沙坦
中文同义词: 2-乙氧基-1-[[2'-(4,5-二氢-5-氧代-1,2,4-恶二唑-3-基)联苯-4-基]甲基]苯并咪唑-7-羧酸;阿齐沙坦
英文名称: Azilsartan
英文同义词: AZILSARTAN;2-Ethoxy-1-[[2'-(4,5-dihydro-5-oxo-1,2,4-oxadiazol-3-yl)biphenyl-4-yl]methyl]benzimidazole-7-carboxylic acid;Tak 536;Unii-F9nux55p23
AZILVA® Now Available for a Treatment of Hypertension in Japan Osaka, Japan, May 28 2012 --- Takeda Pharmaceutical Company Limited (“Takeda”) announced today that AZILVA (generic name: azilsartan) is now available for the treatment of hypertension in Japan. Discovered by Takeda, azilsartan is an angiotensin II receptor blocker (“ARB”) that lowers blood pressure by blocking the action of angiotensin II, a vasopressor hormone. Azilva is a once-daily, orally administered single tablet, and the available doses are 20 mg and 40 mg.
There were four phase 3 trials of AZILVA conducted in Japan for submission. One of the four phase 3 trials, was a multi-centre, double-blind study* with 636 patients of grade I and II hypertension to evaluate the efficacy and safety of AZILVA in comparison with Blopress® (generic name: candesartan cilexetil), another ARB discovered and marketed by Takeda in Japan. The trial showed AZILVA was superior to Blopress with statistical significance in lowering the change from baseline in sitting diastolic blood pressure. In addition, AZILVA was also superior to Blopress with statistical significance in lowering the mean diastolic blood pressure and systolic blood pressure in 24 hours, daytime and night time as well as in the early morning time, measured by Ambulatory Blood Pressure Monitoring (ABPM). AZILVA was safe and well tolerated, with the safety profile comparable to Blopress.
Masato Iwasaki, Senior Vice President, Pharmaceutical Marketing Division of Takeda, remarked that “Hypertension is one of the major risk factors for all cardiovascular diseases including cerebrovascular disease and myocardial infarction. According to the Japanese Society of Hypertension’s Guidelines for the Management of Hypertension (JSH 2009), there are about 40 million hypertensive patients in Japan, with about half of that number said to be not receiving satisfactory treatment. In the situation where strict management of blood pressure is required for these patients, we believe that AZILVA, having strong and persistent hypotensive effects, may offer a new therapeutic option. We will continue our earnest efforts to provide drug information for AZILVA that will be more useful for both Japanese patients and medical specialists”.
Takeda launches Azilva for blood pressure in Japan Takeda Pharmaceutical has launched its once-daily angiotensin II receptor antagonist Azilva as a treatment for high blood pressure in Japan.
Azilva (azilsartan medoxomil) will be made available in two doses - 20mg and 40mg - and will be targeted at patients who struggle to meet their blood pressure targets despite current treatment, according to Takeda.
The company said it expects sales of around 3.5bn yen ($45m) in fiscal 2012, while analysts have predicted that it could achieve sales of $700m or more per year at peak, despite being a later entrant into the crowded angiotensin receptor blocker (ARB) category.
In phase III trials, azilsartan was found to lower blood pressure more effectively than three rival angiotensin II receptor antagonists, namely Novartis' Diovan (valsartan), Takeda's own Blopress (candesartan cilexetil) and Daiichi Sankyo's Benicar/Olmetec (olmesartan).
The key to its success will lie in its superior profile to existing ARBs, and how effectively Takeda can market that message in light of the fact that cheaper, generic alternatives to valsartan and losartan are already available.
"There are about 40m hypertensive patients in Japan, with about half of that number said to be not receiving satisfactory treatment," commented Masato Iwasaki, senior vice president, pharmaceutical marketing at Takeda.
"In the situation where strict management of blood pressure is required for these patients, we believe that Azilva, having strong and persistent hypotensive effects, may offer a new therapeutic option," he added.
The product was launched last year in the US and Europe under the Edarbi brand name, and a line extension formulation called Edarbyclor, which combines azilsartan with the diuretic chlorthalidone, was introduced in the US in April, 2012.
It is the only fixed-dose combination of an ARB and chlorthalidone on the market
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