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AstraZeneca Decides to Withdraw ExantaTM
The following is a press release from AstraZeneca. You may also review this press release and obtain additional information from the Exanta website at http://www.exanta.com.
Patients must not stop taking their tablets without speaking to their doctor.
AstraZeneca today announced that the company has decided to withdraw the anticoagulant ExantaTM (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 Regulatory files in OS and other indications in the US, Europe and elsewhere will now be withdrawn.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 may 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."
14 February, 2006
Edel McCaffrey, Tel: +44 (0) 207 304 5034
Steve Brown, Tel: +44 (0) 207 304 5033
Mina Blair, Tel: +44 (0) 207 304 5084
Jonathan Hunt, Tel: +44 (0) 207 304 5087
Ed Seage, Tel: +1 302 886 4065
Jorgen Winroth, Tel + 1 212 579 0506
A Few Notes on Exanta
Exanta is also known as ExartaTM in Italy and Sweden.
Exanta is marketed for up to 11 day use in prevention of venous thromboembolic events (VTE) in patients undergoing elective hip or knee replacement surgery.
Countries where Exanta is marketed are Germany, Portugal, Sweden, Finland, Norway, Iceland, Austria, Denmark, France, Switzerland, Argentina and Brazil.
Countries where Exanta is approved but not marketed are Belgium, Spain, The Netherlands, Luxembourg, Greece, Indonesia, Hong Kong, Italy, Russia and Ukraine.
In 2005 total sales of Exanta were $575,000
The development of AZD0837, which has the same mode of action as Exanta but is chemically different, will continue as planned.
For patient and physician enquiries AstraZeneca contact details, by country, are available on the www.exanta.com website.
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