Vasogen Inc. announced that it has been granted CE Mark regulatory approval in Europe for its lead product, Celacade (immune modulation therapy), for the treatment of chronic heart failure. This regulatory approval positions Vasogen to market Celacade in the 15 member countries of the European Union, where it is estimated that chronic heart failure affects more than five million people. Vasogen plans to launch Celacade in Europe upon the successful completion of its ongoing pivotal phase III ACCLAIM trial in patients with advanced chronic heart failure.
"Receipt of regulatory approval for the treatment of chronic heart failure in Europe underscores the excellent safety profile of our product and enables Vasogen to launch Celacade in the second largest healthcare market in the world, following the successful completion of the company's pivotal phase III ACCLAIM trial," commented David Elsley, CEO of Vasogen. "In addition to demonstrating our continuing commitment to quality assurance and manufacturing excellence, this approval also strengthens Vasogen's position in ongoing partnering discussions."
Vasogen is currently conducting the 2,000-patient pivotal phase III ACCLAIM trial in advanced chronic heart failure patients, which is designed to support regulatory approvals and the commercial introduction of Celacade™ in North America and Europe. The ACCLAIM trial is based on results from Vasogen's phase II trial, which demonstrated a significant reduction in the risk of death and hospitalization among advanced heart failure patients receiving Celacade.
Heart failure is a debilitating condition in which the heart's ability to function as a pump is impaired, most frequently as a result of coronary artery disease or hypertension. Patients with heart failure experience a continuing decline in their health, resulting in an increased frequency of hospitalization and premature death. It is estimated that there are more than 10 million people with chronic heart failure in North America and Europe. The average five-year survival rate for all patients with heart failure is approximately 50 per cent. In the United State alone, there are approximately 300,000 deaths associated with chronic heart failure each year and the cost of medical care, primarily resulting from hospitalization, exceeds $19 billion annually.