Medicines Company Receives Not Approvable Letter From FDA for Angiomax

The Medicines Company has received a not approvable letter from the FDA on a supplemental new drug application for an additional dosing regimen for Angiomax in the treatment of acute coronary syndromes initiated in the emergency department.

The FDA indicated that the basis of its 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 primary basis of the filing was the Acuity trial, whose results were 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.