European mutual recognition procedure approves 32 mg dose for Atacand®

Main Category: Cardiovascular / Cardiology
Article Date: 13 Aug 2004 - 15:00 PDT

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AstraZeneca today announced that the European Mutual Recognition Procedure (MRP) for a 32 mg tablet of its important antihypertensive drug Atacand® (candesartan cilexetil) has been completed. The UK was the Reference Member State for the European Mutual Recognition Procedure for marketing approval across other EU countries*.

Clinical studies have shown that once daily Atacand® has a dose-related antihypertensive effect over the entire dose range to 32 mg1. The extensive data indicate that, particularly in hypertensive patients who are not adequately controlled with Atacand® 16 mg once daily, a dose increase to 32 mg results in additional blood pressure reduction2. The 32 mg dose of Atacand® has been available in the US since 1998.

The higher dose of 32 mg was the target dose in the CHARM* Programme, evaluating Atacand® in heart failure, for which AstraZeneca submitted a European regulatory application in April this year. The submission followed the positive results of the CHARM Programme, first presented at the European Society of Cardiology in August 2003. CHARM proved Atacand® to be the first AT1-receptor blocker to reduce both cardiovascular deaths and hospital admissions for heart failure, across a broad spectrum of patients with chronic heart failure3.

Gunnar Olsson, VP and Head of the Cardiovascular Therapy Area, said: "This is an important step in the use of Atacand® in the treatment of hypertension, and will mean that physicians have an additional treatment option available when deciding how best to manage patients, particularly where monotherapy is favoured over combination therapy."

Contact information

Elizabeth Rickard - Ketchum Mobile: +44 7786 246 618 Office: +44 20 7611 3633
Email: elizabeth.rickard@ketchum.com

Anette Orheim - Mobile: +46 709 13 19 52 Office: +46 46 33 80 87
Email: anette.orheim@astrazeneca.com

Stephanie Gardner - Ketchum, London office Office: +44 20 7611 3510 Mobile: +44 7779 300 685
Email: stephanie.gardner@ketchum.com