FDA approved Angiomax for pediatric use.
FDA has granted The Medicines Company pediatric exclusivity for Angiomax®, an anticoagulant, for another six months. The agency will thus not authorize commercialization of generic versions prior to September 2010.
The Medicines Company explains that Angiomax is a direct thrombin inhibitor with a naturally reversible mechanism of action and 25-minute half-life. In the U.S., Angiomax is indicated in patients undergoing angioplasty and in patients with or at risk of heparin-induced thrombocytopenia and thrombosis syndrome undergoing angioplasty. In addition, Angiomax is indicated for use as an anticoagulant in patients with unstable angina undergoing percutaneous transluminal coronary angioplasty.
The firm reported that net revenue in the U.S. for Angiomax increased 31% to $334.2 million for 2008 from $255 million for 2007. Net revenue outside the U.S. went up 444% to $13.6 million compared to $2.5 million in 2007. Guidance provided by The Medicines Company for 2009 puts total revenues at $425 million to $445 million.
Approval in children 16 years and below was based on a prospective, openlabel, multicenter, 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 to less than 2 years), undergoing multiple types of catheter-based treatment for their congenital heart abnormalities.
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, Angiomax safely provided the expected anticoagulant effect, according to The Medicines Company.
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