EMEA Approves First Therapeutic Produced in Transgenic Goat

Filed in archive Drugs, Vaccines and Therapeutics , Food and Agriculture , Genomics, Proteomics and Bioinformatics on June 7, 2006

Following a re-examination, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMEA) has recommended approval for GTC Biotherapeutics' ATryn, a recombinant anti-clotting agent produced in the milk of genetically engineered goats. The CHMP recommended its use as prophylaxis of venous thromboembolism in surgery of patients with congenital antithrombin deficiency.

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.

This is an important milestone, marking the approval of the first recombinant drug produced in a transgenic animal. More details from GTC Biotherapeutics' press release.