E.U. MR application completed for Arimidex.(breast cancer treatment completes European Union's Mutual Recognition Process)

2002 DEC 19 - (NewsRx.com & NewsRx.net) -- AstraZeneca announced that it has successfully completed the European application (under the Mutual Recognition Process) for the use of Arimidex as adjuvant treatment in postmenopausal women with early breast cancer.

The U.K. Medicines Control Agency (MCA) was the Reference Member State for the MR application with Austria, Germany, Italy, Portugal, and Spain as Concerned Member States.

With this news, 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 these E.U. countries, giving physicians and patients a real choice for treatment. It is also the first and only endocrine therapy to have shown benefits over tamoxifen in early stage breast cancer. Completion of the E.U. MR process is based on the ground-breaking first results from the ATAC (Arimidex, Tamoxifen Alone or in Combination) trial, which showed Arimidex to have significant benefits, in terms of both efficacy and tolerability, compared with tamoxifen, the current gold standard treatment in this setting.

Arimidex is already approved as an adjuvant treatment for postmenopausal women with hormone receptor-positive early breast cancer in the U.S., New Zealand, Belgium, and Luxembourg, and can be promoted in this setting in Japan and Mexico. The drug is also already licensed worldwide for use in postmenopausal women with advanced disease, where it has become the world's leading aromatase inhibitor with over 650,000 patient years experience. Global Arimidex sales in 2001 were $191 million, a 22% increase ...