The Food and Drug Administration has issued its first approval for a medication that is produced using material from genetically engineered (GE) animals.
ATryn, as the drug is known, is an anticoagulant used for the prevention of blood clots in patients with a rare disease known as hereditary antithrombin (AT) deficiency.
It is formulated as a protein derived from the milk of goats whose genes have been manipulated by introducing a segment of DNA (called a recombinant DNA or rDNA) with instructions to produce human antithrombin in its milk.
Antithrombin naturally occurs in healthy people and prevents blood from clotting.
To preempt the expected criticism from the natural products industry, the FDA quoted scientists from the Center for Veterinary Medicine who said that based on their observations of seven generations of the GE goats they have not discovered any adverse effects from the rDNA or its expression.
According to the National Alliance for Trombosis and Trombophilia, about 1 in 5,000 Americans has AT deficiency, and these patients are at high risk for clotting during surgery and childbirth.
Until now, the only AT drug available in the U.S. was derived from human blood donors.