The Medicines Company (MDCO) Granted Pediatric Exclusivity from FDA for Angiomax
The Medicines Company (NASDAQ: MDCO) announced today that the U.S. FDA has granted pediatric exclusivity for Angiomax (bivalirudin), 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 old. With this additional six months of exclusivity, the FDA will not authorize commercialization of generic versions of bivalirudin prior to September 2010.
"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, IL.
The submission was based on a prospective, open-label, multi-center, single arm study evaluating Angiomax as a procedural anticoagulant in the pediatric population undergoing intravascular procedures for congenital heart disease. The trial enrolled 110 patients (less than 16 years of age), including 11 neonates (less than 30 days) and 33 infants/toddlers (30 days - less than 2 years), undergoing multiple types of catheter-based treatment for their congenital heart abnormalities. Patients were given a 0.75 mg/kg bolus loading dose and a 1.75 mg/kg/hr infusion for the duration of the procedure.
Study outcomes suggest that the pharmacokinetic (PK) and pharmacodynamic (PD) response of Angiomax in the pediatric population is predictable and behaves in a manner similar to that in adults. Using weight based dosing, as currently approved in adults, Angiomax safely provided the expected anticoagulant effect in the pediatric population undergoing intravascular procedures for congenital heart disease.
"These data, similar to previous studies in adults, once again demonstrate that Angiomax is safe and allows for predictable anticoagulation across a broad spectrum of patients undergoing percutaneous procedures, including pediatric patients with life threatening heart conditions," said John Kelley, President and Chief Operating Officer of The Medicines Company. "While pediatric trials can be challenging, we are committed to providing critical care medicines that reliably and cost-effectively deliver meaningful clinical advantages for patients in need."
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