Atryn may be given in association with heparin or low molecular weight heparin in these situations. The positive opinion of the advisory board recommends granting market authorization under procedures for exceptional circumstances. Final market authorization by the European Commission is expected in about three months.
Upon approval, Atryn will be the first antithrombin product approved for use in all 25 countries of the European Union. Atryn will also be the only available antithrombin product that is produced by recombinant biotechnology and is not derived from the human blood supply.
“It is a good day for European patients with congenital antithrombin deficiency and for their physicians,” said Professor Isobel Walker, consultant hematologist at Glasgow Royal Infirmary. “Atryn provides an alternative to treatment with human plasma derived antithrombin and gives physicians and patients more choice in how they will be treated.”
GTC said that it further anticipates using the results from both the completed study reviewed by the European advisory board and an ongoing pivotal phase III study to prepare a biologics license application for the US FDA.
The results of the pivotal phase III study will also be submitted for consideration by European regulators for expansion of the use of Atryn in Europe to prevent deep vein thromboses and thromboembolisms in women with a hereditary antithrombin deficiency who are undergoing childbirth.