The Food and Drug Administration announced the approval of the first drug made from a genetically engineered animal.
The drug is called Atryn and is developed by GTC Biotherapeutics Inc. The product is made from the milk of genetically altered goats and is designed to treat a rare blood-clotting disorder known as hereditary antithrombin deficiency. The goats were scientifically altered to produce a protein that acts as a natural blood thinner.
Currently, those who suffer from hereditary anithrombin deficiency have to take conventional blood thinners, like Plavix from Bristol-Myers Squibb and Sanofi-Aventis. The situation will change, however, thanks to this new discovery. Statistics show that about 1 in 5,000 people don't produce enough antithrombin protein.
The new drug is only approved for intravenous use when patients are undergoing surgery or having a baby, when the risk of blood clots is particularly high, according to the Associated Press.
GTC Biotherapeutics (NASDAQ: GTCB) and partner Ovation Pharmaceuticals of Deerfield, IL hope they will be able to introduce the drug to the market before the end of June.
“Advancing this novel technology from the early days of demonstrating its capability to the daily practice of producing a safe and efficacious product for the U.S. and the European Union, is a testament to the persistence and capability of our employees,” said Geoffrey Cox, GTC’s chairman and CEO, said in a statement.
“The approval of ATryn marks a significant milestone in the development of this innovative recombinant technology,” the company said in a statement.
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