The decision by the FDA to approve new prescribing information for Angiomax (bivalirudin) is effective immediately. The label will now include patients undergoing percutaneous coronary intervention (PCI) in addition to those undergoing percutaneous transluminal coronary angioplasty (PTCA). The decision was based on data from the REPLACE-2 trial which evaluated Angiomax with provisional glycoprotein IIb/IIIa inhibitors (GPI in PCI.
Dr Michael Lincoff, lead investigator and professor of medicine at The Cleveland Clinic commented: “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 label also includes a new Angiomax dosing recommendation, the same as that 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. Medical publications report that the REPLACE-2 dose enables streamlined patient care at significantly reduced costs.
The Medicines Company plans to launch promotional programs based on the expanded label in the coming weeks. Shares in the company rose 5.5 % to $23.69 in morning trading following the announcement of the FDA decision.