Pharma News

UK MHRA grants authorisation for breast cancer prevention drug

The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has granted authorisation for Anastrozole to prevent breast cancer in postmenopausal women. 

Anastrozole has been authorised to be given as a preventative treatment for postmenopausal women at moderate or high risk.

An inhibitor of aromatase, Anastrozole is indicated for use as a 1mg tablet to be taken once daily for five years. 

It acts by reducing levels of the hormone oestrogen in the body.

The latest development is based on data from the IBIS-II study of hormone therapy.

In the global, placebo-controlled, double-blind, randomised trial, Anastrozole treatment resulted in fewer cases of breast cancer in women versus the placebo arm.    

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Hot flushes, weakness, joint pain or stiffness, skin rash, arthritis and nausea were the most frequent side effects associated with the drug.

Anastrozole was previously authorised to treat breast cancer in post-menopausal women.  

It is now repurposed as a preventive option for breast cancer under the Medicines Repurposing Programme led by NHS England.

Accord Healthcare carried out the licensing activities linked to the medicine.

MHRA chief executive Dame June Raine stated: “This innovative programme is essential to support and advance research into medicines that might be repurposed, increase access to life-saving medicines and, ultimately, improve patients’ lives. 

“The MHRA welcomes applications for repurposed medicines and encourages early dialogue from companies or developers considering this.”

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