FDA Approves Genetic Modification in Pigs for Biomedicine and Food

T.The US Food and Drug Administration approved a genetically modified pig line yesterday (December 14). This is the first time a genetically modified animal has received regulatory green for therapeutic development and food consumption, the agency said in a statement. The alteration eliminates alpha-gal, a sugar molecule on the surface of cells, and could help minimize allergic reactions to pork and reduce the risk of organ rejection in transplant patients.

The move represents an “enormous milestone for scientific innovation,” said FDA Commissioner Stephen Hahn in the statement. “The FDA strongly supports the advancement of innovative animal biotechnology products that are safe for animals and humans and that achieve the intended results.”

Genetically modified pigs are known as GalSafe pigs and are manufactured by Revivicor Inc, a subsidiary of US biotech United Therapeutics. Research in the mid-2010s showed that the knockout made pig transplants less likely to be rejected by primate recipients.

See “Xenograft Record”

The director of the FDA’s Center for Veterinary Medicine, Steven Solomon, told reporters on a conference call yesterday that developers who want to use GalSafe pigs for therapeutic purposes have yet to obtain approval for their applications. “I think people have to be careful,” said Solomon. STAT Reports. “Because of this, some further evaluation of xenografts, xenografts, or other activities by medical device centers and the FDA is required.”

With regard to food production, the statement states that the meat is safe for the general population and that Revivicor “intends to sell meat from GalSafe pigs by mail order rather than in supermarkets”.

The agency’s assessment also found that GalSafe pigs pose a low risk to the environment, with an impact “no greater than that of conventional pigs”. It adds that “GalSafe pigs have not identified any animal safety concerns beyond those expected in well-managed commercial pig populations”.

Several other efforts are under way around the world to develop genetically modified pigs, including some changes aimed at making pigs grow faster and others aimed at making animals more resistant to deadly viruses such as the swine reproductive and respiratory syndrome virus (PRRSV) do.

See “The superpowers of genetically modified pigs”

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