FDA blocks generic sales of bivalirudin for pediatric heart patients

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The FDA has granted pediatric exclusivity for the Medicines Company's Angiomax (bivalirudin). With this additional six months of exclusivity, the FDA will 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 evaluating Angiomax as a procedural anticoagulant in pediatric patients, from birth to 16 years old, undergoing intravascular procedures for congenital heart disease, according to the Parsippany, N.J.-based company.

The trial included 110 patients (less than 16 years of age), including 11 neonates (less than 30 days) and 33 infants/toddlers (30 days to less than two 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 and pharmacodynamic 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, the company said that Angiomax safely provided the anticoagulant effect in the pediatric population undergoing intravascular procedures for congenital heart disease.

The FDA may grant a drug additional marketing exclusivity if a company conducts clinical studies in certain pediatric populations at the written request of the FDA, Medicines said. This provision is designed to encourage further investigation into the unmet medical needs of the pediatric population and was established under the Best Pharmaceuticals for Children Act of 2002.