Saturday, February 7, 2009
WASHINGTON: FDA OKs 1st drug from genetically altered animals 06.feb.09 Associated Press Ricardo Alonso-Zaldivar New York Times Andrew Pollack WASHINGTON -- The Food and Drug Administration made history Friday as it approved the first drug made with materials from genetically engineered animals, clearing the way for a new class of medical therapies. GTC Biotherapeutics said regulators cleared its drug ATryn, which is manufactured using milk from goats that have been scientifically altered to produce extra antithrombin, a protein that acts as a natural blood thinner. The drug's approval may be the first step toward new kinds of medications made not from chemicals, but from living organisms altered by scientists. Similar drugs could be available in the next few years for a range of human ailments, including hemophilia. The FDA cleared the drug to treat patients with a rare hereditary disorder that causes a deficiency of the protein, putting them at higher risk of deadly blood clots. The injectable treatment will be marketed in the U.S. by Deerfield, Ill.-based Ovation Pharmaceuticals The 200 goats, which are assiduously cared for at a secure farm in central Massachusetts, contain a human gene that causes them to produce a human blood protein in their milk. After the goats are milked, the protein can be extracted for sale as a drug. Such “pharm animals” as they are sometimes called, could become a way of producing biotechnology drugs at lower cost or in greater quantities than the existing methods, which are to extract them from donated blood or to grow genetically engineered cells in steel tanks.
Posted by akilah (Mimi Drake) at 11:13 PM