The Medicines Company announced receipt of a not approvable letter from the US Food and Drug Administration (FDA) on a supplemental New Drug Application (sNDA) for an additional dosing regimen for Angiomax (bivalirudin) in the treatment of acute coronary syndromes (ACS) initiated in the emergency department.
The primary basis of the filing was the Acuity trial, whose results have been published in New England Journal of Medicine, Journal of the American Medical Association and Lancet. The company believes that the Acuity results are consistent with those demonstrated in clinical trials of over 47,000 patients across a broad spectrum of cardiovascular risk, including: Replace-2, BAT, and most recently, the Horizons-AMI trial. These trials demonstrate that utilizing Angiomax instead of heparins not only provides comparable protection against ischemic events but also reduces bleeding and costs.
The FDA indicated that the basis of their decision involved the appropriate use and interpretation of non-inferiority trials, including Acuity. The Company disagrees with the Agency on these issues and has initiated discussions to address them.
The Medicines Company reaffirmed its 2008 Angiomax US sales guidance of $310 to $320 million. Angiomax continues to grow patient share in the cardiac catheterization lab, where it is currently promoted. As of March 2008, over 44 percent of patients undergoing percutaneous coronary intervention (PCI) receive Angiomax as their baseline anti-coagulant.
Angiomax is a direct thrombin inhibitor with a naturally reversible mechanism of action and 25 minute half-life. In clinical trials, treatment with Angiomax resulted in improved clinical outcomes with significantly reduced rates of major bleeding compared to heparin plus glycoprotein IIb/IIIa inhibitor (GPI) across the entire spectrum of risk in patients undergoing PCI and numerically lower rates of 1-year mortality in patients undergoing PCI.
The Medicines Company is focused on advancing the treatment of critical care patients through the delivery of innovative, cost-effective medicines to the worldwide hospital marketplace.