Exanta completes Mutual Recognition Procedure
Exanta (ximelagatran), AstraZeneca's new oral anticoagulant for short-term use in prevention of venous thromboemolic events (VTE) in hip or knee replacement surgery, has successfully completed the Mutual Recognition Procedure (MRP) in Europe.
Exanta (ximelagatran), AstraZeneca's new oral anticoagulant for short-term use in prevention of venous thromboemolic events (VTE) in hip or knee replacement surgery, has successfully completed the Mutual Recognition Procedure (MRP) in Europe.
France acted as the Reference Mamber State, with approval in this first market achieved last December.
National marketing authorisations for a further 14 countries will be issued in the coming months. Ireland and the UK have been withdrawn from the MRP and regulatory discussions will be held to agree the appropriate route to secure Exanta's approval in orthopaedic surgery in these countries.
Exanta is the first oral therapy in a new class of direct thrombin inhibitors. It is currently under regulatory review in the EU for key chronic-use indications including prevention of stroke and other thromboembolic complications associate with atrial fibrillation and the treatment of venous thromboembolism. FDA submissions were file in December in the US for stroke prevention in patients with atrial fibrillation and long-term secondary prevention of VTE, as well as for use of Exaota in prevention of VTE in major elective orthopaedic surgery.