AstraZeneca plc conducted a clinical development program in over 30,000 patients and persuaded European regulators to allow Exanta ximelagatran on the market. But last week, the company only managed to persuade one voting participant in an FDA advisory committee meeting to support the use of Exanta for any indication.
On Friday, the Cardiovascular and Renal Drugs Advisory Committee and its consultants voted 11-1 and 10-1 with one abstention, respectively, that AstraZeneca failed to demonstrate a favorable risk-benefit ratio for two long-term indications for Exanta: prevention of stroke and other thromboembolic complications associated with atrial fibrillation, and long-term secondary prevention of venous thromboembolism (VTE) after standard treatment of an episode of acute VTE.
The panel also unanimously rejected one short-term indication: prevention of VTE in patients undergoing knee replacement surgery.
The European indication is prevention of VTE following major elective orthopedic surgery (hip or knee replacement). Acting as the reference member state for the Mutual Recognition Procedure, France approved Exanta in December 2003. The product was launched in Germany on June 21.
AstraZeneca (LSE:AZN; AZN, London, U.K.) characterized the indication as a "proof of principle" in press releases announcing the approval, and emphasized that applications for blockbuster markets in chronic indications are pending in Europe and the U.S. It also noted that "the worldwide market for anticoagulants is around $4 billion and growing at 13 percent annually, while the worldwide anti-thrombotic market is around $12 billion, growing at 15 percent annually."