14th Feb 2006 14:00
AstraZeneca PLC14 February 2006 AstraZeneca Decides to Withdraw ExantaTM Patients must not stop taking their tablets without speaking to their doctor. AstraZeneca today announced that the company has decided to withdraw theanticoagulant ExantaTM (melagatran / ximelagatran) from the market and terminateits development. AstraZeneca estimates that approximately 400 patients arecurrently being prescribed the drug for short-term prevention of venousthromboembolism (VTE) following orthopaedic surgery (OS). Two ongoing Exantaclinical trials will be discontinued and Exanta-treated patients switched toother treatments. It is important that patients do not stop Exanta treatmentwithout consulting their doctor. Regulatory files in OS and other indications inthe US, Europe and elsewhere will now be withdrawn. The withdrawal of Exanta has been triggered by new patient safety data (anadverse event report of serious liver injury) in the EXTEND clinical trial. Thetrial examines use of Exanta in extended VTE prophylaxis in OS up to 35 dayspost-operatively, and so involves a longer duration of therapy than currentlyapproved for marketing. Liver findings have previously been observed duringclinical trials of chronic use as referred to in the prescribing information.This new patient report indicates a potential risk of severe liver injury, withan observation of rapid onset of signs and symptoms in the weeks following theend of the 35 days treatment. This specific observation has not previously beenmade in relation to Exanta and indicates that regular liver function monitoringmay not mitigate the possible risk. While there is no evidence of a risk ofliver injury with approved use up to 11 days, any unapproved use beyond 11 daysis a concern. Therefore, in the interests of patient safety, AstraZeneca istaking the precautionary measure of withdrawing Exanta. AstraZeneca hasinformed regulatory authorities of its decision to withdraw Exanta and is nowcommunicating with all prescribers and healthcare professionals to advise themthat no new patients should be started on Exanta. For patients currently taking Exanta, doctors should consider changing treatmentto an alternative anticoagulant while taking account of individual patientcircumstances and ensuring uninterrupted anticoagulation. The small number ofcurrent Exanta patients should be contacted by their doctor and reviewedpromptly to avoid any unplanned discontinuation of therapy. AstraZeneca willmaintain the supply of Exanta for a short period to allow doctors to managepatients during this transition. David Brennan, Chief Executive Officer, AstraZeneca PLC commented: "We havedecided to take this precautionary action in the interests of patient safety.There are a number of alternative options for short-term post-operativeanticoagulation following orthopaedic surgery. We would like to recognise theinvolvement of doctors, patients and scientists and their commitment to thedevelopment of Exanta over the past years. Thrombosis is one of the greatestthreats to human health and represents a significant public health burden.AstraZeneca remains committed to the discovery and development of new medicinesin this area to help improve patients' lives." -Ends- 14 February, 2006 Media Enquiries:Edel McCaffrey, Tel: +44 (0) 207 304 5034Steve Brown, Tel: +44 (0) 207 304 5033 Investor Enquiries:Mina Blair, Tel: +44 (0) 207 304 5084Jonathan Hunt, Tel: +44 (0) 207 304 5087Ed Seage, Tel: +1 302 886 4065Jorgen Winroth, Tel + 1 212 579 0506 Notes to editors: * 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 This information is provided by RNS The company news service from the London Stock ExchangeRelated Shares:
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