AstraZeneca files in EU for new Arimidex use
AstraZeneca has applied to the European Union for a licence extensionfor its aromatase inhibitor Arimidex (anastrozole) to include its use as a treatment for post-menopausal women with early-stage breast cancer. The UK is acting as the reference member-state for EU approval.
Arimidex is already licensed worldwide for use in post-menopausal women with more advanced breast cancer, but the extended licence application is based on the results of the ATAC study of 9,300 women which showed that Arimidex is significantly more effective and has important tolerability benefits compared with tamoxifen as an adjuvant treatment (Marketletter December 17, 2001).
Arimidex was recently approved for this indication in Japan, and a similar application has been filed for fast-track review in the USA. Sales of the drug reached $191 million in 2001, a 22% rise over 2000, while AstraZeneca's Nolvadex (tamoxifen) accounted for $630 million.
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