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AstraZeneca decides to withdraw Exanta(TM)

Patients must not stop taking their tablets without speaking to their doctor.

AstraZeneca have announced that the company has decided to withdraw the anticoagulant Exanta? (melagatran/ximelagatran) from the market and terminate its development. AstraZeneca estimates that approximately 400 patients are currently being prescribed the drug for short-term prevention of venous thromboembolism (VTE) following orthopaedic surgery (OS). Two ongoing Exanta clinical trials will be discontinued and Exanta-treated patients switched to other treatments. It is important that patients do not stop Exanta treatment without consulting their doctor. Regulatory files in OS and other indications in the US, Europe and elsewhere will now be withdrawn.

The withdrawal of Exanta has been triggered by new patient safety data (an adverse event report of serious liver injury) in the EXTEND clinical trial. The trial examines use of Exanta in extended VTE prophylaxis in OS up to 35 days post-operatively, and so involves a longer duration of therapy than currently approved for marketing. Liver findings have previously been observed during clinical trials of chronic use as referred to in the prescribing information. This new patient report indicates a potential risk of severe liver injury, with an observation of rapid onset of signs and symptoms in the weeks following the end of the 35 days treatment. This specific observation has not previously been made in relation to Exanta and indicates that regular liver function monitoring might not mitigate the possible risk. While there is no evidence of a risk of liver injury with approved use up to 11 days, any unapproved use beyond 11 days is a concern. Therefore, in the interests of patient safety, AstraZeneca is taking the precautionary measure of withdrawing Exanta. AstraZeneca has informed regulatory authorities of its decision to withdraw Exanta and is now communicating with all prescribers and healthcare professionals to advise them that no new patients should be started on Exanta.

For patients currently taking Exanta, doctors should consider changing treatment to an alternative anticoagulant while taking account of individual patient circumstances and ensuring uninterrupted anticoagulation. The small number of current Exanta patients should be contacted by their doctor and reviewed promptly to avoid any unplanned discontinuation of therapy. AstraZeneca will maintain the supply of Exanta for a short period to allow doctors to manage patients during this transition.

David Brennan, Chief Executive Officer, AstraZeneca PLC commented: "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. 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."