Regulatory Approval
AstraZeneca PLC
05 May 2004
SUCCESSFUL OUTCOME OF THE MUTUAL RECOGNITION PROCEDURE FOR EXANTATM
(XIMELAGATRAN) IN EUROPE
AstraZeneca announced today that it has successfully completed the Mutual
Recognition Procedure (MRP) in Europe for ExantaTM (ximelagatran) for short-term
use in the prevention of venous thromboembolic events in major elective
orthopaedic surgery (hip or knee replacement) - the 'proof of concept'
indication for this new anticoagulant.
France acted as the Reference Member State for the MRP, with approval in this
first market achieved in December 2003. National Marketing Authorisations for
an additional 14 countries will be issued in the coming months. UK and Ireland
have been withdrawn from the MRP and regulatory discussions will be held to
agree the appropriate route to secure approval of Exanta in orthopaedic surgery
in these countries.
Dr Hamish Cameron, Vice President, Head of Exanta, AstraZeneca, said, 'As Exanta
is the first new oral anticoagulant in nearly 60 years, completion of this first
regulatory review in orthopaedic surgery is a historic milestone as we approach
the introduction of this innovative new therapy.'
Completion of the MRP for this first indication for Exanta was based on the
extensive clinical programme and in particular the METHRO III study. The
approved treatment regimen involves an early postoperative start of Exanta, with
initial injectable dosing administered 4-8 hours after the completion of
surgery, followed by oral Exanta 24mg twice daily for up to 11 days. This
approach reflects the changing trends in clinical practice across Europe with
increasing use of spinal anaesthesia as well as enabling oral treatment, to be
easily continued following discharge from hospital.
More than half of patients undergoing major orthopaedic surgery can develop
thromboembolic complications in the absence of preventative anticoagulant
treatment, and while effective treatments are available, no treatment regimen to
date has successfully balanced efficacy and bleeding risk with oral dosing.
Exanta is the first oral therapy in a new class of direct thrombin inhibitors to
protect patients against thrombosis. Exanta is currently under regulatory
review in the E.U. for key chronic-use indications including the prevention of
stroke and other thromboembolic complications associated with atrial
fibrillation and the treatment of venous thromboembolism (VTE).
In the US, FDA submissions were filed in December 2003 for stroke prevention in
patients with atrial fibrillation and long-term secondary prevention of VTE, as
well as for use of Exanta in prevention of VTE in major elective orthopaedic
surgery (knee replacement).
The worldwide market for anticoagulants is around $4 billion and growing at 13
per cent annually, while the worldwide anti-thrombotic market is around $12
billion, growing at 15 per cent annually.
Exanta is a trademark of the AstraZeneca group of companies. European MRP
countries include: Austria, Belgium, Denmark, Finland, France, Germany, Greece,
Ireland, Italy, Luxembourg, the Netherlands, Portugal, Spain, Sweden, United
Kingdom, Iceland and Norway
METHRO: MElagatran for THRombin inhibition in Orthopaedic surgery is a study
that compared injectable low molecular weight heparins initiated the evening
before surgery, with preoperative (METHRO II) or post-operative (METHRO III)
initiation of melagatran (active form) followed by oral ximelagatran in 4,688
patients undergoing total hip or knee replacement.
5 May 2004
Media Enquiries:
Steve Brown, +44 207 304 5033 or Edel McCaffrey, +44 207 304 5034
Investor Enquiries:
Mina Blair-Robinson, +44 207 304 5084 or Jonathan Hunt, +44 207 304 5087
-Ends-
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