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FDA Approves Expansion of Bivalirudin Label
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.
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. Please see full prescribing information available at http://www.angiomax.com. Angiomax is marketed under the tradename Angiox(TM) in Europe.
Source: The Medicines Company