FDA Approves New Prescribing Info for Bivalirudin
Jun 17, 2005 - 9:50:00 AM
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The expanded label now includes patients undergoing percutaneous coronary intervention (PCI) in addition to those undergoing percutaneous transluminal coronary angioplasty (PTCA).
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By The Medicines Company,
[RxPG] The Medicines Company (NASDAQ: MDCO) today announced that the U.S. Food and Drug Administration (FDA) has approved new prescribing information for Angiomax(R) (bivalirudin).
The expanded label now includes patients undergoing percutaneous coronary intervention (PCI) in addition to those undergoing percutaneous transluminal coronary angioplasty (PTCA). PCI, also referred to as angioplasty, is conducted on approximately 850,000 Americans annually to clear restricted blood flow in arteries around the heart. A. Michael Lincoff, M.D., Professor of Medicine at The Cleveland Clinic was principal investigator of the REPLACE-2 trial, which evaluated Angiomax with provisional glycoprotein IIb/IIIa inhibitors (GPI) use in PCI. Dr. Lincoff commented, "Addition of REPLACE-2 data in Angiomax prescribing information is an important milestone. The large-scale REPLACE-2 trial demonstrated that Angiomax with provisional GPI reduces the risk of death, heart attack, and repeat procedures following coronary intervention. Relative to the use of heparin and GPI, Angiomax with provisional GPI showed significantly less risk of bleeding, lower cost, and greater ease of use."
The new label is effective immediately. The Company plans to launch promotional programs based on the expanded label in the coming weeks. Kim Carroll, General Manager of The Medicines Company's Interventional and Emergency Medicines Business Unit, said, "This event signals the start of additional and substantial support for Angiomax as we continue to grow the brand."
The label also includes a new Angiomax dosing recommendation, which is the same used in REPLACE-2. The new dose has a smaller bolus (0.75 mg/kg) and a smaller infusion (1.75 mg/kg/h) for the duration of the procedure, instead of a four hour infusion. Medical publications report that the REPLACE-2 dose enables streamlined patient care and significantly reduced costs.
Clive Meanwell, The Medicines Company's Chairman and CEO, stated, "We are pleased with the FDA approval of the new prescribing information which now includes the PCI indication, a lower dose, and discussion of the REPLACE-2 trial. In its approval letter, FDA said the totality of evidence indicates that Angiomax with provisional use of GPI is safe and effective for anticoagulation during PCI, including placement of intracoronary stents. The Agency also noted in the letter, however that, in their view, 'statistical non-inferiority was not demonstrated for the triple (ischemic) endpoint' at 30-days in the REPLACE-2 trial. As published in the Journal of the American Medical Association, the REPLACE-2 investigators concluded non-inferiority was established for the 30-day ischemic endpoint. The one-year mortality data also supported non -inferiority conclusions for Angiomax with provisional GPI and this, together with the consistency of effect, is, we believe, persuasive."
The Medicines Company has an additional sNDA filed with FDA for the use of Angiomax in patients with heparin-induced thrombocytopenia and thrombosis syndrome, or HIT/TS undergoing PCI. The Medicines Company expects FDA action on the HIT/TS PCI sNDA in the second half of 2005.
ABOUT ANGIOMAX(R) (BIVALIRUDIN) FOR INJECTION
Angiomax is a reversible antithrombotic agent with a short-half life (25 minutes). In clinical trials, Angiomax has demonstrated excellent ischemic protection while simultaneously reducing bleeding complications compared to heparin as the foundation anticoagulant in the contemporary catheterization lab setting. Angiomax with provisional use of glycoprotein IIb/IIIa inhibitors (GPI) is indicated for use as an anticoagulant in patients undergoing percutaneous coronary intervention (PCI). Angiomax is intended for use with aspirin. The most common adverse events reported in clinical trials with Angiomax were back pain, pain, nausea, headache, and hypotension. The incidence of these adverse events was comparable in both treatment groups in these trials. An unexplained fall in blood pressure or hematocrit, or any unexplained symptom, should lead to serious consideration of a hemorrhagic event and cessation of Angiomax administration. Angiomax is contraindicated in patients with: active major bleeding, hypersensitivity to Angiomax or its components.
Publication:
U.S. Food and Drug Administration (FDA)
On the web:
www.angiomax.com 
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Additional information about the news article
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Please see full prescribing information available at http://www.angiomax.com. Angiomax is marketed under the tradename Angiox(TM) in Europe.
About The Medicines Company
The Medicines Company meets the demands of the world's most advanced medical practitioners by developing products that improve acute hospital care. The Company markets Angiomax(R) (bivalirudin), an anti-clotting therapy approved in the U.S. and other countries for use in patients undergoing coronary angioplasty, a procedure to clear restricted blood flow in arteries around the heart. The Medicines Company creates value using its range of clinical and commercial skills to develop products acquired from leading life science innovators. The Company's website is http://www.themedicinescompany.com.
Statements contained in this press release about The Medicines Company and Angiomax that are not purely historical may be deemed to be forward-looking statements for purposes of the safe harbor provisions under The Private Securities Litigation Reform Act of 1995. Without limiting the foregoing, the words "believes," "anticipates" and "expects" and similar expressions are intended to identify forward-looking statements. These forward-looking statements involve known and unknown risks and uncertainties that may cause the Company's actual results, levels of activity, performance or achievements to be materially different from those expressed or implied by these forward-looking statements. Important factors that may cause or contribute to such differences include the extent of the commercial success of Angiomax, physicians' acceptance of Angiomax clinical trial results such as the results of REPLACE-2, whether the Company will be able to obtain regulatory approval for additional indications of Angiomax on a timely basis or at all, and such other factors as are set forth in the risk factors detailed from time to time in the Company's periodic reports and registration statements filed with the Securities and Exchange Commission including, without limitation, the risk factors detailed in the Company's Quarterly Report on Form 10-Q filed on May 6, 2005, which are incorporated herein by reference. The Company specifically disclaims any obligation to update these forward-looking statements.
Contacts
The Medicines Company
Michael Mitchell, 973-656-1616
[email protected]
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