FDA OKs use of transgenic chicken for drug production

"Using this technology, these patients for the first time ever have access to a treatment," said Janet Woodcock, director of the FDA's Center for Drug Evaluation and Research.
By Brooks Hays  |  Dec. 9, 2015 at 1:45 PM
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WASHINGTON, Dec. 9 (UPI) -- Most drugs are synthesized in the lab, but scientists are now finding ways to pass off some of the synthesis work to farm animals. This week, the U.S. Food and Drug Administration approved the use of the first drug-producing transgenic chicken.

Drug company Alexion Pharmaceuticals has created a genetically modified chicken that lays eggs featuring the drug Kanuma, (sebelipase alfa), a recombinant human enzyme used to treat a rare genetic disorder.

People with lysosomal acid lipase deficiency, or LAL, an inherited disorder, produce a faulty version of the enzyme used to break down fatty molecules inside cells. Kanuma serves as a stand-in for the enzyme.

The chicken-produced enzyme is found inside the whites of the laid eggs. The genetically modified chickens only do part of the work. The enzyme must be isolated by scientists and concentrated.

"LAL deficiency is a rare inherited genetic disorder that can lead to serious and life-threatening organ damage, especially when onset begins in infancy," Janet Woodcock, director of the FDA's Center for Drug Evaluation and Research, said in a press release. "Using this technology, these patients for the first time ever have access to a treatment that may improve their lives and chances of survival."

Federal regulators reviewed both the drug's efficacy in treating human patients, as well as the ethics of transgenic chicken technology. Specifically, federal scientists wanted to ensure the genetic modifications didn't cause the animals undue harm.

Researchers with Alexion say the chicken is raised indoors, and is not at risk of finding its way into populations of chickens raised for food.

The FDA has previously approved a blood clot-fighting coagulant drug made in the milk of genetically modified goats.

"[The decision] shows that the ATryn goats weren't just a one-off," Jay Cormier, a former scientific reviewer for the FDA, now a lawyer in the nation's capital, told Nature. "The process can function for more than just one particular unique case."

Earlier this year, federal regulators approved plans to raise and sell genetically modified salmon as food in the United States. The designer salmon could be in grocery stores within a few years -- unlabeled.

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