AZ files for extension

Published: 17-May-2002
Regulatory


AstraZeneca has filed for a licence extension under the EU Mutual Recognition Procedure for Arimidex, for the treatment of postmenopausal women with early-stage breast cancer. Arimidex is already licensed worldwide for use in post-menopausal women with advanced disease.

This extended licence application, which uses the UK as reference member state, is based upon the results of a study of more than 9,300 women, which showed that Arimidex is significantly more effective and has important tolerability benefits compared with tamoxifen as an adjuvant treatment in postmenopausal women with early breast cancer.

The US FDA recently granted a six-month Priority Review Status to the supplemental new drug application (sNDA). The sNDA was submitted in early March under the 'fast track' submission process.

AZ expects early breast cancer licence approvals later this year.

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