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Medicines Co. receives FDA approval of Angiomax label expansion for coronary intervenion
By E. Janene Geiss
Philadelphia, Dec. 1 - The Medicines Co. announced Thursday that the U.S. Food and Drug Administration approved the use of Angiomax (bivalirudin) in patients with or at risk of heparin-induced thrombocytopenia (HIT) and thrombosis syndrome (HITTS) while undergoing percutaneous coronary intervention.
HIT/HITTS are complications of heparin administration that can have devastating clinical consequences for patients, including limb amputation, renal failure and even death, according to a company news release.
This Angiomax label expansion is the second in 2005, officials said.
In June, the label was expanded to include percutaneous coronary intervention in addition to patients undergoing percutaneous transluminal coronary angioplasty.
This most recent label expansion includes results from the AT-BAT trial of 51 patients with HIT/HITTS undergoing PCI, officials said.
"We hope to continue demonstrating that replacing heparin with Angiomax leads to better outcomes, particularly in high risk patients, such as those with HIT/HITTS," said John Kelley, president and chief operating officer, in the release.
"The updated Angiomax label will allow for broader dissemination of information to interventional cardiologists and, now, hematologists regarding the role of Angiomax in this high-risk patient population," Kelley said.
The company said it is planning a future registry study in hospitals to further evalute Angiomax because HIT/HITTS is not well understood in clinical practice.
The company said it also is evaluating the use of Angiomax in the recently completed CHOOSE trials of patients with or at-risk of HIT/HITTS undergoing cardiac surgery and anticipates submitting an FDA application for another Angiomax label expansion to include those patients.
The Medicines Co. is a Parsippany, N.J., pharmaceutical company focused on development of acute care hospital products.
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