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AstraZeneca Secures US Approvals, Recovers Rights To Brazikumab

Mon, 11th May 2020 09:25

(Alliance News) - AstraZeneca PLC on Monday revealed progress for its cancer treatments in the US as it said it has recovered the rights to Brazikumab from Allergan PLC.

The FTSE 100-listed pharmaceutical company said that its drug Enhertu - jointly-developed with Japanese peer Daiichi Sankyo Co Ltd- has been granted breakthrough therapy designation in the US for metastatic gastric cancer.

The designation, granted by the US Food & Drug Administration, is designed to accelerate the development and regulatory review of potential new medicines intended to treat a serious condition and address a significant unmet medical need.

Separately, AstraZeneca said that its Lynparza treatment, combined with bevacizumab has been approved in the US as first-line maintenance treatment for HRD-positive advanced ovarian, fallopian tube or primary peritoneal cancer.

Astra said the FDA's decision was based on results showing that the treatment reduced the risk of disease progression or death by 67%, with the combined treatments improving progression-free survival to an average of 37.2 months compared with 17.7 months with bevacizumab alone.

In a separate statement, the pharmaceutical giant said it has terminated its license agreement with Allergan and has recovered the global rights to brazikumab. Under the termination agreement, Allergan will pay total costs expected to be incurred by AstraZeneca until completion of the development of brazikumab.

Brazikumab is currently being developed as a treatment for Crohn's disease and ulcerative colitis which are autoimmune diseases that cause the gut to become inflamed. Both conditions can result in diarrhoea, fatigue, weight loss, and pain. At present, neither Crohn's nor ulcerative colitis are curable.

AstraZeneca shares were trading 0.6% higher at 8,613.00 pence each on Monday morning in London. Shares in Daiichi Sankyo closed 1.5% lower at JPY7,635 each in Japan.

By Ife Taiwo; ifetaiwo@alliancenews.com

Copyright 2020 Alliance News Limited. All Rights Reserved.

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