The FDA considers the recommendations of its advisory committees when making its determinations. If approved, ATryn will be the first recombinant human antithrombin available in the US, said GTC Biotherapeutics.
In September 2008, the FDA assigned priority review to GTC’s biologic license application (BLA) for ATryn. Priority review is granted to applications for products that, if approved, would provide significant advances in treatment or provide a treatment where no sufficient one already exists. Under priority review, the FDA’s target date for action on the BLA is February 7, 2009. GTC has licensed ATryn to Ovation to develop and market it in the US.
Geoffrey Cox, GTC’s chairman and CEO, said: We are very pleased with the advisory committee’s recommendation in support of the safety and efficacy of ATryn. ATryn is the first transgenically produced therapeutic to achieve approval in Europe and undergo review by the FDA.
ATryn is also a testament to our established strength in recombinant technology, and has the potential to provide an important new treatment option for patients with hereditary antithrombin deficiency.