FDA approves anticoagulant bivalirudin for use in unstable angina

Julia Rommelfanger

December 18, 2000

Mon, 18 Dec 2000 19:44:43

Cambridge, MA - The Medicines Company has received FDA clearance to market their thrombin-specific anticoagulant bivalirudin (Angiomax?) for use in patients with unstable angina undergoing percutaneous transluminal coronary angioplasty (PTCA), the company announced. The agent, the company said, is intended to replace heparin, but at this point should only be given to patients receiving concomitant aspirin.

"The FDA's approval of Angiomax provides interventional cardiologists with a better option for anticoagulation - our first opportunity to replace heparin in the cath lab," said Dr Eric Topol (Cleveland Clinic Foundation), member of the company's Medical Advisory Board. "Heparin continues to present problems related to bleeding and thrombotic complications and this is a significant step forward for patient care."

The FDA had signaled approval for the agent in a letter to the company in May 2000, as previously reported by heart wire . The agency, according to The Medicines Company, had based their market clearance for bivalirudin on clinical trial data of 4312 patients undergoing PTCA for new onset angina, accelerating episodes of angina, or angina at rest.

Bivalirudin vs heparin in unstable angina patients undergoing PTCA


Events

Bivalirudin

Heparin

Risk reduction*

6.2%
7.9%
22%
3.5%
9.3%
62%
*with bivalirudin compared to heparin treatment

Bivalirudin was found to be a safe and effective anticoagulant, which significantly improved clinical outcomes compared to heparin. The reductions in the incidence of death, MI, revascularization, and major bleeding with bivalirudin were sustained at 90 days and 6 months. These lower incidence rates caused 68 fewer patients to experience adverse and costly outcomes for every 1000 patients treated, the company stated.

"With launch activities well underway, we expect to make the product available to patients in January," said Clive Meanwell (President and CEO, The Medicines Company). The scheduled launch date is January 15, 2001.

Several clinical studies are underway, said Meanwell, to investigate the anticoagulant for additional indications, such as the HERO-2 trial, which is expected to enroll 17000 patients with acute MI, with results expected at the end of 2001, and the REPLACE study of bivalirudin in patients undergoing percutaneous coronary intervention. In addition, the thrombin inhibitor is being investigated for use in conjunction with GpIIb/IIIa inhibitors.

The Medicines Company estimates bivalirudin to be priced at $335 per vial, with one vial proven to provide "safe and effective anticoagulation for standard risk patients," according to Meanwell.

[Dr Topol is the editor-in-chief of theheart.org]



Related links

1. [Heartwire > News; May 17, 2000]

2.


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