The US Food and Drug Administration (FDA) has awarded pediatric exclusivity to The Medicines Company for Angiomax (bivalirudin) and will not authorise commercialisation of a generic version prior to September 2010.
The decision to grant an additional six months of exclusivity was granted based on studies submitted in response to a written request by the FDA, for paediatric patients aged under 16.
The submission was based on a prospective, open-label, multi-centre, single-arm study. The study was intended to evaluate Angiomax as a procedural anticoagulant in the paediatric population undergoing intravascular procedures for congenital heart disease.
The trial enrolled 110 patients under 16 years of age, including 11 neonates (less than 30 days) and 33 infants/toddlers (30 days – less than two 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.