Statement of Policy: As a general rule, MedicineNet.com does not publish press releases from companies or private interest groups. However, we have made an exception here because Exanta is the first oral anticoagulant since the introduction of warfarin almost 60 years ago. Exanta has not been approved for use in the United States.
FIRST LAUNCH FOR ASTRAZENECA'S EXANTA™ (XIMELAGATRAN): THE FIRST ORAL ANTICOAGULANT IN NEW CLASS OF DIRECT THROMBIN INHIBITORS (DTIS)
Exanta™ (ximelagatran), a new anticoagulant and the first oral treatment in the new class of direct thrombin inhibitors (DTIs), is launched today in Germany in its first indication: the prevention of venous thromboembolic events (VTE) in elective hip or knee replacement surgery (orthopaedic surgery). Exanta is the first oral anticoagulant since the introduction of warfarin almost 60 years ago, and is the product of over 20 years' research and development at AstraZeneca. It was developed to provide a solution to the significant unmet medical need for a new, predictable and well-tolerated oral therapy for patients at risk of thrombosis, one of the major causes of cardiovascular morbidity and mortality in the developed world.
The prevention of VTE in orthopaedic surgery is an important proof of principle indication for Exanta and follows the successful completion of the E.U. Mutual Recognition Process for this indication in May 2004. Patients are particularly at risk of thrombosis following orthopaedic surgery, with more than half developing VTE in the absence of preventative anticoagulant treatment. Whilst effective treatments are available, no treatment regimen to date has successfully balanced efficacy and bleeding risk with oral dosing.
The approved label in the E.U. for Exanta in this indication involves an early postoperative start of treatment, 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 supports the increasing use of postoperative initiation of VTE preventative treatment in clinical practice across Europe, and also enables oral treatment to be easily continued following discharge from hospital.
"Clinical studies have shown the potential that Exanta offers as a new approach to the prevention and management of thrombosis. I am excited that this new oral anticoagulant is now becoming available for orthopaedic surgery patients" commented Professor Bengt Eriksson, Department of Orthopaedics, Sahlgrenska/ostra University Hospital, Gothenburg, Sweden, and Lead Investigator in European orthopaedic surgery study programme.
Exanta has been the subject of the largest clinical study programme in anticoagulation to date, involving around 30,000 patients. It is 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 use of Exanta in prevention of VTE in patients undergoing knee replacement surgery as well as for prevention of stroke and other thromboembolic complications associated with atrial fibrillation and long-term secondary prevention of VTE after standard treatment for an episode of VTE.
"Exanta is an innovative new approach to the treatment and prevention of thrombosis," commented Dr Hamish Cameron, Vice President, Head of Exanta, AstraZeneca. "We are proud to be able to launch Exanta in this initial indication, as the first oral anticoagulant in almost 60 years."
As an oral Direct Thrombin Inhibitor, Exanta benefits from a unique mode of action that enables predictable protection against the risk of thrombotic events, administration as a fixed oral dose, a rapid onset and offset of action and low potential for food and drug interactions. Importantly, coagulation monitoring is also not necessary in treatment with Exanta.
National launches will also take place in other European countries, subject to national marketing authorisations, in coming months.
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 will be launched in other E.U. countries in this short term orthopaedic surgery indication throughout 2004. The UK and Ireland withdrew from the mutual recognition process in Europe and regulatory discussions will be held to agree the appropriate route to secure approval of Exanta in orthopaedic surgery in these countries.
- Following the completion of the E.U. Mutual Recognition Process, National Marketing Approvals have so far been granted in Germany, Sweden, Portugal and Iceland
- The approved label for Exanta in the E.U. is based on the METHRO III (MElagatran for THRombin inhibition in Orthopaedic surgery) study, which compared post-operative initiation of melagatran (active form of Exanta) followed by oral ximelagatran in 4,688 patients undergoing total hip or knee replacement.
- The injectable form of Exanta will within most countries be known as Melagatran AstraZeneca ™
Source: Astra Zeneca press release, June 21, 2004