sNDA Gets FDA Approval for Use of Angiomax
September 25, 2007 - The Medicines Company announced that the FDA has accepted its supplemental new drug application (sNDA) for a modified dosing regimen of Angiomax (bivalirudin) for the treatment of acute coronary syndromes (ACS), specifically in patients with unstable angina or non-segment elevation myocardial infarction (NSTEMI), which could replace heparin in patients undergoing angioplasty.
The sNDA includes data from the ACUITY trial, one of the largest ACS clinical trials ever conducted to evaluate anti-thrombotic therapies and enrolled 13,819 high-risk patients in 450 centers worldwide. The trial design employed an early invasive strategy (angiography within 72 hours), starting anti-clotting therapy when ACS patients arrived at the emergency department and randomly assigning them to treatment with standard therapy of heparin (unfractionated or enoxaparin) plus a drug called a glycoprotein IIb/IIIa inhibitor (GPI), Angiomax plus GPI, or the "Angiomax alone" treatment group.
In the Angiomax alone group, selective use of GPIIb/IIIa inhibitor was permitted in limited circumstances, and occurred in less than 10 percent of patients in the ACUITY trial. Based on results of coronary angiography and the clinical judgment of the treating physician, patients were treated for ACS through medical management, bypass surgery or percutaneous coronary intervention (PCI).
“The benefits of replacing heparin with Angiomax in patients undergoing angioplasty are clear and well documented: better clinical outcomes and lower costs,” said John Kelley, president and CEO of The Medicines Company. “The proposed label change would expand the potential use of Angiomax beyond the cardiac cath lab into the emergency department.”
The Medicines Company expects the FDA to act on this filing in the second quarter of 2008. Angiomax is currently approved for patients undergoing PCI.
For more information: www.angiomax.com and www.themedicinescompany.com.