The U.S. Food and Drug Administration approved intentional genomic alteration or IGA in a line of domestic pigs that may be used as food as well as for potential human therapeutics. The approval of the IGA in pigs, which will be called GalSafe pigs, was granted to Revivicor Inc.
The IGA in these pigs would eliminate alpha-gal sugar on the surface of the pigs' cells. People with Alpha-gal syndrome or AGS may have mild to severe allergic reactions to alpha-gal sugar found in red meat, such as beef, pork, and lamb.
According to the regulator, GalSafe pigs may potentially provide a source of porcine-based materials to produce human medical products that are free of detectable alpha-gal sugar.
These pigs could potentially be used as a source of medical products, such as the blood-thinning drug heparin, free of detectable alpha-gal sugar. Tissues and organs from GalSafe pigs could address the issue of immune rejection in patients receiving xenotransplants, as alpha-gal sugar is believed to be a cause of rejection in patients.
For the decision, the FDA evaluated the safety of the IGA for the animals and people eating meat from them, as well as the product developer's intention to market the IGA for its ability to eliminate alpha-gal sugar on pigs' cells.
The FDA also analyzed that the potential impact that the approval of GalSafe pigs would have on the U.S. environment is no greater than from conventional pigs.
FDA Commissioner Stephen Hahn said, "As part of our public health mission, the FDA strongly supports advancing innovative animal biotechnology products that are safe for animals, safe for people, and achieve their intended results."
According to the regulator, this is the first ever approval of an animal biotechnology product for both human food consumption and as a source for biomedical use.
In 2009, the FDA approved genetically altered goats to produce a medicine in their milk for preventing blood clots, and chickens were approved in 2015 that can make a drug in their eggs. Salmon was the first genetically modified animal to be approved for food.
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