Published online 11 February 2009 | Nature 457, 775 (2009) | doi:10.1038/457775e

News in Brief

Transgenic drug gets green light from the United States

The US Food and Drug Administration (FDA) has issued its first approval of a drug produced by a genetically engineered animal.

The drug, marketed as ATryn, is the human blood protein antithrombin and will be used to treat various blood-clotting disorders. It is produced in the milk of transgenic goats engineered by GTC Biotherapeutics, a company based in Framingham, Massachusetts.

The FDA's decision, released on 6 February, had been delayed while the agency worked out how to regulate products made from genetically engineered animals. It finally issued industry guidelines on 15 January this year (see Nature 457, 371; 2009), and it was widely expected that approval of ATryn, which had already been given the green light by a scientific advisory committee, would soon follow. The drug was approved in Europe in June 2006. 

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