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FDA Approves Drug Derived from Genetically Altered Goat Milk

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A herd of bio-engineered goats in Massachusetts, whose milk contains a valuable human protein, is the first of its kind to be approved by the Food and Drug Administration. The milk, which is laced with a human anti-clotting protein called antithrombin, will be used to make the drug ATryn. ATryn is designed for humans born with a rare deficiency of the antithrombin protein. Although individuals with the deficiency can properly treat it with approved blood thinners, risks of dangerous clots are highest during childbirth and surgery, which is when the FDA has cleared ATryn for use. ATryn will be marketed in the United States by Ovation Pharmaceuticals and will be available in the second quarter of 2009.

The FDA studied seven generations of GTC Biotherapeutics’ genetically engineered goats and found no problems with the goats or within the protein itself. GTC scientists combined the human DNA for antihrombin with goat DNA so the goat’s mammary glands would secrete the human protein. The best part of all this? They were able to do so without any harm to the goat

The "pharm animal" is hoping to solve many of the problems pharmaceutical companies face when developing drugs, such as high cost, length of time it takes to manufacture, and shortage of supplies. For example, the supply of antithrombin is often short due to a lack of human donation. But thanks to these new advances, in one year, a single genetically engineered goat can produce as much antithrombin as 90,000 donations, which could potentially cure the shortage problem.

These goats represent the first animal whose sole purpose is to create a drug. Although ethical concerns arise from groups opposing such practice, hopes are that this approval will pave the way for pharmaceutical companies to consider this type of transgenic production for future drugs.