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Fluids & Electrolytes
MONDAY, Feb. 9 (HealthDay News) -- For the first time, the U.S. Food and Drug Administration has approved a product that is produced using genetically engineered animals, according to a release issued by the agency.
On Feb. 6, the FDA issued its approval for the anticoagulant ATryn, which is used in patients with a rare disease, known as hereditary antithrombin deficiency, that puts them at risk of blood clots. The therapeutic protein is derived from the milk of goats that have had a recombinant DNA introduced into their genes to instruct them to produce human antithrombin in their milk. Antithrombin helps prevent blood clots in healthy humans.
The FDA evaluated two studies involving 31 patients with hereditary antithrombin deficiency who received ATryn to prevent thromboemboli before, during or after surgery or childbirth. Only one of the patients developed thromboemboli. The FDA also evaluated the safety of the recombinant DNA for the goats and found no adverse outcomes. The agency designated ATryn, manufactured by GTC Biotherapeutics, Inc. of Framingham, Mass., an orphan drug because antithrombin deficiency occurs in only one in 5,000 people in the United States. The designation is meant to encourage the development of medications for people with rare diseases or conditions.
"This product offers an important new treatment option for patients with hereditary antithrombin deficiency, preventing life-threatening clots that otherwise frequently occur during high-risk situations," Jesse Goodman, M.D., director of the FDA's Center for Biologics Evaluation and Research, said in a statement.
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