FDA Grants The Medicines Company Pediatric Exclusivity For Angiomax

The Medicines Company has received FDA’ pediatric exclusivity for Angiomax (bivalirudin), based on studies submitted in response to a written request by FDA, for pediatric patients aged under 16.

With this additional six months of exclusivity, FDA would not authorize commercialization of generic versions of bivalirudin prior to September 2010.

The submission was based on a prospective, open-label, multi-center, single arm study. The study was intended to evaluate 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 0.75mg/kg bolus loading dose and a 1.75mg/kg/hr infusion for the duration of the procedure.