Heparin alternative Angiomax granted pediatric exclusivity
June 22nd, 2009 by Jennifer Walker-Journey
The Food and Drug Administration (FDA) has granted pediatric exclusivity to The Medicines Company for its anticoagulant Angiomax. The approval is based on studies submitted in response to a Written Request by the FDA to investigate the use of Angiomax in pediatric patients aged birth to 16 years.
“The FDA’s decision responds to the critical need for effective anticoagulant treatments for children undergoing intravascular heart procedures,” said Rolando Zamora, MD, Director of Pediatric Interventional Cardiology, Methodist Children’s Heart Institute, San Antonio, TX.
“There have been very few studies of anticoagulation in children, especially in those undergoing these critical heart procedures, and current agents have major disadvantages in the pediatric population. Angiomax could have an important impact on this young patient population,” said Ziyad Hijazi, MD, Director of the Center for Congenital and Structural Heart Disease, Professor of Pediatrics and Internal Medicine, Rush University Medical Center, Ill.
In clinical trials, treatments with Angiomax resulted in improved clinical outcomes with significantly reduced rates of major bleeding compared to heparin plus GPI across the spectrum of risk in patients undergoing angioplasty, and lower rates of 1-year mortality in patients undergoing angioplasty.
In the U.S., Angiomax with provisional GPI is indicated in patients undergoing angioplasty or at risk of heparin-induced thrombocytopenia and thrombosis syndrome (HIT/HITTS) undergoing angioplasty.
Source: PR Canada.net