FDA Grants First-Ever U.S. Approval of GE Animal Product
WASHINGTON, D.C. (Friday, February 06, 2009) - Advances in human health care from the genetic engineering of animals are now being realized in the United States. The U.S. Food and Drug Administration (FDA) announced today the first approval of a product derived from a genetically engineered (GE) animal.
ATryn®, a recombinant form of human antithrombin developed by GTC Biotherapeutics, was approved by the FDA for the prevention of peri-operative and peri-partum thromboembolic events in hereditary antithrombin deficient patients. It is not indicated for treatment of thromboembolic events in hereditary antithrombin deficient patients. ATryn® is the first ever transgenically produced therapeutic protein and the first recombinant antithrombin approved in the United States.
Along with the approval of ATryn®, the FDA’s Center for Veterinary Medicine also approved GTC’s New Animal Drug Application, the first of its kind to regulate GE animals. This is now required for a recombinant technology used to develop transgenic animals, such as the goats that produce recombinant antithrombin. GTC has granted OVATION the right to market ATryn® in the United States and pursue further clinical development.
Dr. Barbara Glenn, Managing Director for Animal Biotechnology at the Biotechnology Industry Organization (BIO) released the following statement expressing the industry’s support for the FDA’s action today:
"BIO applauds the FDA for approving this product, the first-ever U.S. approval for a product developed with the help of genetic engineering. ATryn® was also approved by the European Medicines Evaluation Agency of the European Commission in August 2006.
"BIO is especially pleased that the approval signals that the U.S. government regulatory process governing GE animals is effective. The regulatory process was clarified in final guidance released by FDA on January 15, 2009. The process ensures the products made available through various applications of genetic engineering will go through a rigorous and transparent review process before being approved for the marketplace.
"Research with GE animals such as goats, pigs, sheep, chicken, fish and cattle, has yielded a variety of products aimed at advancing human health. For example, GE animals can produce pharmaceutical proteins and replacement tissues in their milk, eggs, and blood, which can be used in the treatment of human diseases such as cancer, heart attacks, hemophilia, rheumatoid arthritis, pandemic flu, malaria and small pox. In addition, research is being conducted to produce transplant organs in pigs that may be a source of organs for humans.
"Advancing human health is only one of the many compelling benefits. GE animals are also being developed to enhance food production and quality, mitigate environmental impact, optimize animal welfare and improve state-of-the-art industrial products.
"BIO supports the FDA process for regulating GE animals and their products, which is based on the Food, Drug and Cosmetic Act’s New Animal Drug (NAD) framework. The process is consistent with international guidelines established last year by the Codex Alimentarius Commission. Codex standards are recognized as international benchmarks and act as models for governments in the establishment of their own food safety policies.
"BIO and its members seek to provide to society approved products that have been deemed safe and beneficial."
* For more information on ATryn® or GTC Biotherapeutics, visit www.gtc-bio.com
** The potential of GE animals has been detailed in the report, Genetically Engineered Animals and Public Health – Compelling Benefits for Health Care, Nutrition, the Environment and Animal Welfare, released last year. For more information, visit BIO’s GE Animals Web Resource Page at www.bio.org and visit FDA’s GE Animals Web Resource Page at www.fda.gov/cvm/GEAnimals.htm.
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