1st Drug From Genetically Altered Animals Approved
MONDAY Feb. 9, 2009 -- The first drug made with materials from genetically engineered animals has gained U.S. Food and Drug Administration approval, potentially paving the way for a new class of medical therapies.
GTC Biotherapeutics said federal regulators approved its drug, ATryn, which includes milk from goats that have been genetically altered to produce an extra protein that acts as a natural blood thinner, the Associated Press reported.
The drug will be used to treat the estimated one in 5,000 people with a rare genetic disorder -- hereditary antithrombin deficiency -- that leads to a lack of the protein, leaving them vulnerable to potentially deadly blood clots, the news service said.
Patients with hereditary antithrombin deficiency are currently treated with conventional blood thinners, such as Plavix. That approach won't change with the approval of ATryn. 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, the AP said.
European regulators approved the drug in 2006.
The FDA has additional information about this drug's approval.
Posted: February 2009