The Medicines Company announced that the US Food and Drug Administration (FDA) has granted paediatric exclusivity for Angiomax (bivalirudin), based on studies submitted in response to a Written Request by the FDA to investigate the use of Angiomax in paediatric 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, director of Paediatric Interventional Cardiology, Methodist Children's Heart Institute, Antonio, Texas. "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, director of the Center for Congenital and Structural Heart Disease, Professor of Paediatrics and Internal Medicine, Rush University Medical Center, Illinois.

The submission was based on a prospective, open-label, multi-center, single arm study evaluating Angiomax as a procedural anticoagulant in the paediatric 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 paediatric 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 paediatric 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 paediatric 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."

These data have been presented at this year's Society for Cardiac Angiography and Interventions (SCAI) annual meeting in Las Vegas, NV. The data will also be presented this month at the Paediatric & Adult Interventional Cardiac Symposium (PICS-ACIS) in Cairns, Australia.

The FDA may grant a drug additional marketing exclusivity if a company conducts clinical studies in certain paediatric populations at the written request of the FDA. The granting of additional marketing exclusivity reflects the FDA's determination that the study fairly responded to the FDA's Written Request. This provision is designed to encourage further investigation into the unmet medical needs of the paediatric population and was established under the Best Pharmaceuticals for Children Act of 2002.

Angiomax is a direct thrombin inhibitor with a naturally reversible mechanism of action and 25 minute half-life.

The Medicines Company is focused on advancing the treatment of critical care patients through the delivery of innovative, cost-effective medicines to the worldwide hospital marketplace.