(NaturalNews) The FDA has issued its first-ever approval for a drug produced with ingredients from a genetically engineered animal.
The injectable drug, known as A Tryn, has received FDA approval to treat a rare genetic condition that causes the body to produce insufficient quantities of the naturally occurring blood-thinning protein antithrombin. The drug was produced by GTC Biotherapeutics using goats that had been genetically engineered to produce excess antithrombin in their milk, and will be marketed in the United States by Ovation Pharmaceuticals.
Scientists engineered the goats by modifying the section of the human genetic code responsible for producing antithrombin, then injecting those gene fragments into goat embryos. The genetically modified embryos were then implanted into surrogate goat mothers and raised to adulthood.
Antithrombin
deficiency is a rare condition, affecting approximately one person in 5,000. Low levels of the
protein can lead to the formation of clots in the
blood, which can then travel through the
body and lodge fatally in the lungs or brain -- 50 percent of
patients experience at least one life-threatening blood clot before the age of 25. The condition also increases the
risk of miscarriage or stillbirth in pregnant women.
Even with the new
FDA approval, the disorder will continue to be treated primarily with conventional blood thinners, except in patients who are about to undergo surgery or
childbirth.
Surgery and childbirth both significantly increase the risk of dangerous blood clots in patients with antithrombin deficiency.
The
drug approval is the first since
the FDA issued its guidelines in January for products made from
genetically engineered animals. Under the new policy, all such
products must be reviewed by a panel of independent experts at a public meeting before receiving final approval.
Critics have objected that such a process does not adequately assess the potential impacts of genetically engineered organisms on the environment, and does not require the labeling of products containing genetically engineered ingredients.
Sources for this story include: finance.yahoo.com.
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