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AstraZeneca LP (AZN) Secures Approval For Two New Dosage Strengths Of Atacand Plus  
2/9/2009 3:59:22 PM

9th February 2009 – AstraZeneca today announced it had received approval for two new dose strengths of Atacand Plus, aimed at hypertensive patients who are not optimally controlled by monotherapy alone. The decentralised procedure - including eleven EU member states and Iceland, and with Sweden as reference member state - ended positively, and national approvals will follow.

The approval is for new dose strengths of the fixed dose combination Atacand Plus, an angiotensin receptor blocker (candesartan cilexetil) 32mg combined with a diuretic (hydrochlorothiazide - HCT), in doses of either 12.5mg or 25mg. The new dose strengths provide doctors with two effective and well tolerated therapeutic options for hypertensive patients who have had difficulties in reaching blood pressure targets with monotherapy alone. Research shows that in more than two-thirds of hypertensive individuals, blood pressure is not controlled on one drug and will require two or more antihypertensive agents selected from different drug classes. (1) In Europe, Atacand Plus has until now only been available in doses up to 16 mg of candesartan cilexetil in combination with HCT.

The clinical studies supporting this approval show that the new doses of Atacand Plus are effective in providing improved blood pressure reduction and blood pressure control with maintained tolerability in hypertensive patients whose blood pressure is not optimally controlled with candesartan cilexetil or HCT monotherapy. (2,5,6) Current guidelines indicate that treatment with a once daily fixed dose combination also improves patient compliance. (3)

“For clinicians with patients who have had difficulty reaching blood pressure targets with monotherapy, these two new fixed dose combinations now give them a further option to help their patients reach their goal” commented Professor Bönner, Medical Director of MEDIAN clinics, Bad Krozingen, Germany. "Treatment with Atacand Plus has shown effective reduction in blood pressure levels as compared to monotherapy, with a maintained tolerability."

Approximately one billion people worldwide are affected by hypertension, with 7.6 million premature deaths (about 13.5 per cent of the global total) and about 54 per cent of stroke and 47 per cent of ischaemic heart disease attributable to high blood pressure. Hypertension is also a major risk factor for chronic heart failure. (4) For high risk patients tighter blood pressure control is important, as even moderately raised blood pressure can pose significant health risks. The higher a patient’s blood pressure is, the greater the risk of myocardial infarction, heart failure and kidney disease. In diabetic patients, control of blood pressure is particularly critical.

Björn W Karlson, Senior Research Physician at AstraZeneca added: “The new higher dose strengths of Atacand Plus add to the broad range of Atacand hypertension options and offer physicians new solutions with proven efficacy and very good tolerability to help their hypertensive patients achieve their blood pressure targets.”

The trials supporting the new dose strengths included a study with an eight-week single-blind run-in phase on candesartan cilexetil 16mg (for two weeks) and 32mg followed by an eight-week randomised, double-blind phase with three parallel treatment groups (candesartan cilexetil 32mg, candesartan cilexetil-HCT 32/12.5mg or candesartan cilexetil-HCT 32/25mg). (2) Another study with a five-week placebo run-in, randomised patients to an eight-week double-blind treatment with placebo, HCT 25mg, candesartan cilexetil 32mg or candesartan cilexetil-HCT 32/25mg. (5) A third study consisted of an eight-week double-blind treatment period with patients randomized to placebo, HCT 12.5 mg, candesartan cilexetil 32 mg, or candesartan cilexetil-HCT 32/12.5mg. (6)

In this program of clinical studies, Atacand Plus at these high doses was generally well tolerated, and substantial blood pressure reductions were apparent within four weeks of treatment.

About candesartan (Atacand® and Atacand® Plus)

Atacand (candesartan cilexetil) is an angiotensin receptor blocker (ARB), indicated for the treatment of patients with hypertension and patients with chronic heart failure (CHF) and left ventricular systolic dysfunction.

Atacand acts on the renin-angiotensin system (RAS), which plays an important role in regulating blood pressure. Angiotensin II, the main effector hormone in the RAS, mediates a wide range of responses such as vasoconstriction, sodium and fluid retention, cell growth, and sympathetic activation. Atacand binds to the AT1-receptor, thereby blocking its interaction with angiotensin II. This blockade leads to vasodilatation and a decrease in blood pressure. Atacand is at least as effective as other antihypertensive drugs and with the advantage of the good tolerability profile associated with ARBs. (7)

Atacand was first launched for hypertension in 1997 and is currently approved and marketed in over 110 countries around the world. In 2004 Atacand received the first approval for the treatment of CHF in patients with left ventricular systolic dysfunction.

Atacand Plus is a fixed dose combination of candesartan cilexetil and hydrochlorothiazide in doses of 8/12.5 mg, 16/12.5mg, 32/12.5 and 32/25mg. Atacand Plus is indicated for the treatment of essential hypertension in patients who are not optimally controlled by monotherapy alone.

Candesartan cilexetil is marketed by AstraZeneca under trademark Atacand®, Ratacand®, and the fixed dose combination with hydrochlorothiazide is marketed under trademark Atacand® Plus, Atacand® Plus mite, Atacand® Zid, Hytacand®, and Ratacand® Plus and is manufactured under the license from Takeda Pharmaceutical Company Ltd.

About AstraZeneca

AstraZeneca is a major international healthcare business engaged in the research, development, manufacturing and marketing of meaningful prescription medicines and supplier for healthcare services. AstraZeneca is one of the world's leading pharmaceutical companies with healthcare sales of US$ 31.6 billion and is a leader in gastrointestinal, cardiovascular, neuroscience, respiratory, oncology and infectious disease medicines. For more information about AstraZeneca, please visit: www.astrazeneca.com

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