First European approval for AstraZeneca's Crestor

Published: 1-Dec-2002
Regulatory


Crestor (rosuvastatin), AstraZeneca's new statin, has received approval from the Medicines Evaluation Board (MEB) in the Netherlands for the management of primary hypercholesterolaemia and mixed dyslipidaemia. The approval covers dosages from 10-40mg and follows clinical trial results that showed that Crestor was more effective in lowering LDL-cholesterol than currently prescribed statins.

The Netherlands MEB will now act as the reference member state for the European mutual recognition procedure, leading to approvals in 16 other countries starting in the first half of next year. Crestor is also awaiting approval in the US, Japan and other markets. A submission will be made to the FDA in the first quarter of 2003, and the review period in Japan will also be concluded some time next year.

The global statin market is valued at US$18bn (€17.8bn) and grew by 17% in 2001, despite the withdrawal of Lipobay/Baycol (cerivastatin). With the increasing prevalence of coronary heart disease (CHD) and the fact that only half of all eligible patients receive treatment, the market could reach $20-25bn (€19.8-24.7bn) by 2005.

In comparative studies with atorvastatin, more patients reached their LDL cholesterol target with Crestor - more than 80% on the starting dose of 10mg by week 52. At the same time Crestor offers a very favourable benefit:risk ratio, according to Dr Hamish Cameron, vice president and head of cardiovascular therapy area at AstraZeneca, with a safety profile comparable to that of other statins.

The company has also received approval under the European mutual recognition process for Arimidex (anastrozole) as an adjuvant treatment in postmenopausal women with early breast cancer.

Already approved as an adjuvant treatment for postmenopausal women with hormone receptor-positive early breast cancer in the US, New Zealand, Belgium and Luxembourg, Arimidex will become the first and only aromatase inhibitor available for use in the adjuvant treatment of early invasive breast cancer in postmenopausal women in the UK, Austria, Germany, Italy, Portugal and Spain. It is also the first and only endocrine therapy to have shown benefits over tamoxifen in early stage breast cancer.

The drug is also already licensed worldwide for use in postmenopausal women with advanced disease, and has become the world's leading aromatase inhibitor with global sales of $191m (€189m) in 2001, a 22% increase over the previous year.

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