News | September 24, 2007

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.

Related Content

Abbott Initiates XIENCE Short DAPT Clinical Trial
News | Antiplatelet and Anticoagulation Therapies| August 03, 2017
Abbott recently announced the first patient has been enrolled in a clinical study evaluating the short-term use of...
Study Discovers Anticoagulant Drugs Are Being Prescribed Against Safety Advice
News | Antiplatelet and Anticoagulation Therapies| July 25, 2017
July 25, 2017 — A study by researchers at the University of Birmingham has shown that general practitioners (GPs) are
long-duration dual anti-platelet therapy (L-DAPT) compared to short-duration dual antiplatelet (S-DAPT) after DES stent implantation
News | Antiplatelet and Anticoagulation Therapies| July 12, 2017
June 12, 2017 — Researchers have evaluated the long-term efficacy and safety of long-duration dual anti-platelet ther
Sex-Specific Cardiovascular Drug Dosages Needed to Reduce Adverse Reactions in Women
News | Womens Healthcare| July 07, 2017
Sex-specific cardiovascular drug dosages are needed to reduce adverse reactions in women, according to a position paper...
Bayer Now Enrolling Patients for Global Pulmonary Arterial Hypertension Study
News | Hypertension| July 05, 2017
Bayer has enrolled the first patient in a global Phase IV study assessing the clinical effects of riociguat in patients...
FDA Grants Priority Review of Xarelto sNDA for 10 mg Dose
News | Antiplatelet and Anticoagulation Therapies| June 29, 2017
Janssen Research & Development LLC announced the U.S. Food and Drug Administration (FDA) accepted for Priority...
radial access, transradial access trial using anticoagulants
News | Radial Access| June 15, 2017
June 15, 2017 — In patients undergoing t...
Cost comparison between NOACs, novel oral anticoagulants
News | Antiplatelet and Anticoagulation Therapies| May 31, 2017
May 31, 2017 – The results from the first real-world, matched head-to-head study comparing all-cause healthcare costs
Data was positive from the Watchman Left Atrial Appendage Closure (LAAC) Device from the EWOLUTION registry
News | Atrial Fibrillation| May 30, 2017
May 30, 2017 — Data was positive for safety and efficacy rates of the Watchman Left Atrial Appendage Closure (LAAC) D
Statins Associated With Improved Heart Structure and Function
News | Pharmaceuticals| May 26, 2017
Statins are associated with improved heart structure and function, according to research presented at EuroCMR 2017, May...
Overlay Init