Daily Newsletter

07 November 2023

Daily Newsletter

07 November 2023

UK’s MHRA grants authorisation for breast cancer prevention drug

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

Vishnu Priyan November 07 2023

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.    

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.”

Significant unmet need in the Diabetic nephropathy (DN) market for products that can treat DN effectively without side effects

With only a few approved drugs currently available to treat DN by means other than regulation of blood pressure, innovator products that can treat by targeting other factors such as treatment of dyslipidemia, hypertension, or angiotensin inhibition, among others, is a key area of R&D in the DN space and is likely to pave the way for novel therapies in the near future. However, the treatment landscape is expected to remain unchanged due to limited availability of products in the late-stage pipeline currently.

Newsletters by sectors

close

Sign up to the newsletter: In Brief

Visit our Privacy Policy for more information about our services, how we may use, process and share your personal data, including information of your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address.

Thank you for subscribing

View all newsletters from across the GlobalData Media network.

close