AstraZeneca withdraws Exanta

AstraZeneca is to withdraw the anticoagulant Exanta (melagatran/ximelagatran) from the market and end its development.

The venous thromboembolism (VTE) treatment has been withdrawn due to new data about the possibility of liver damage.

AstraZeneca chief executive David Brennan said: “We have decided to take this precautionary action in the interests of patient safety.

“There are a number of alternative options for short-term post-operative anticoagulation following orthopaedic surgery. We would like to recognise the involvement of doctors, patients and scientists and their commitment to the development of Exanta over the past years.”

He added: “Thrombosis is one of the greatest threats to human health and represents a significant public health burden. AstraZeneca remains committed to the discovery and development of new medicines in this area to help improve patients’ lives.”

AstraZeneca will continue to supply the drug in the short-term to allow doctors the chance to switch patients to other treatments.

The decision was taken after the Extend clinical trial found extended use of the drug for 35 days, longer than currently approved duration of 11 days, indicated a potential risk of serious liver damage.

This risk had previously not been noted, but the firm pointed out that while “there is no evidence of a risk of liver injury with approved use up to 11 days, unapproved use beyond 11 days is a concern”.

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