Exanta strikes out
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...