MA for GTC Bio's ATryn goes to Leo
US firm GTC Biotherapeutics says that the market authorization of ATryn for the prophylaxis of venous thromboembolism in surgery of patients with congenital antithrombin deficiency has been transferred to its distribution and development partner, Denmark-based Leo Pharma A/S, following approval by the European Commission. ATryn is a recombinant form of human antithrombin.
The approval of the transfer of the MA enables Leo to enter into negotiation of reimbursement rates as part of preparing for the commercial launch of ATryn in Europe on a country-by-country basis. The initial launch is being planned for around the end of the second quarter of 2007.
In addition, Leo is conducting a Phase II study of ATryn in Europe for the treatment of disseminated intravascular coagulation associated with severe sepsis. The Danish firm has initiated the regulatory approval procedures to enable the opening of clinical sites and recruitment of patients into the study. GTC is continuing to supply the product to Leo to conduct this study.
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