The Food and Drug Administration has for the first time approved an intentional genomic alteration, or IGA, in animals that can be used for both food and human therapeutics.

The IGA is in what are called GalSafe pigs, bred to eliminate alpha-gal sugar on the surface of the pigs’ cells. “People with Alpha-gal syndrome (AGS) may have mild to severe allergic reactions to alpha-gal sugar found in red meat,” such as beef, pork and lamb, FDA said.

“The first-ever approval of an animal biotechnology product for both food and as a potential source for biomedical uses represents a tremendous milestone for scientific innovation,” FDA Commissioner Stephen Hahn said on a conference call Monday.

Developed by Virginia-based company Revivicor, the GalSafe pigs “may potentially provide a source of porcine-based materials to produce human medical products that are free of detectable alpha-gal sugar,” FDA said.

For example, the pigs "could potentially be used as a source of medical products, such as the blood-thinning drug heparin, free of detectable alpha-gal sugar," FDA said. "Tissues and organs from GalSafe pigs could potentially address the issue of immune rejection in patients receiving xenotransplants, as alpha-gal sugar is believed to be a cause of rejection in patients.”

Xenotransplantation “is any procedure that involves the transplantation, implantation or infusion into a human recipient of either live cells, tissues, or organs from a nonhuman animal source, or human body fluids, cells, tissues or organs that have had ex vivo contact with live nonhuman animal cells, tissues or organs,” FDA says on its website. “The development of xenotransplantation is, in part, driven by the fact that the demand for human organs for clinical transplantation far exceeds the supply.”

But FDA said at this point, the GalSafe pigs have not been evaluated as xenotransplantation products for human subjects. “Developers of any such human medical products must first submit an application to, and obtain approval from, the FDA before these products can be used in human medicine,” the agency said.

Alpha-gal syndrome is also known as mammalian meat allergy, according to an informational website set up by AGS expert Scott Commins at the University of North Carolina School of Medicine. “In the U.S., the Lone Star Tick appears to be the primary vector of sensitization.”

“Reactions to alpha-gal are often severe and sometimes fatal,” according to Commins’ website. “They can be immediate, as with hypersensitivity reactions to injected drugs, or delayed by 2 to 10 hours, as is typical after consumption of mammalian meat. Delayed-onset reactions often occur in the middle of the night.”

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Steven Solomon, director of FDA’s Center for Veterinary Medicine, said although FDA has determined GalSafe pigs are safe for consumption by the general public, the developer has not made a specific claim for consumption by people with AGS. Therefore, “the FDA’s review process did not evaluate food safety specific to those with AGS,” the agency said.

In addition, FDA has not reviewed any medical products as yet. Revivicor “now needs to work with other folks to then get review of the different medical products that have the potential to be used,” he said.

Dewey Steadman, head of investor relations for Revivicor owner United Therapeutics, said the company is evaluating commercial opportunities for GalSafe, "including food and medical applications using outside parties experienced in those development programs and distribution systems."

In addition, "For whole pig organs, United Therapeutics is working on xenotransplantation programs, now in preclinical studies, using porcine hearts and kidneys to help address the shortage of transplantable organs for human use. The GalSafe approval is one step in our long-term vision for those programs."

The National Pork Producers Council's Director of Science and Technology, Dan Kovich, said “NPPC remains firm that, in order for the tremendous potential of gene editing to be safely and readily available to U.S. farmers, regulatory authority for all agricultural applications of these new technologies has to be consolidated at the USDA.”

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