The US Food and Drug Administration granted approval yesterday (December 14) for a genetically modified line of pigs that marks the first time a GM animal has been given the regulatory greenlight for both therapeutic development and food consumption, the agency says in a statement. The alteration knocks out 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 a “a tremendous milestone for scientific innovation,” FDA Commissioner Stephen Hahn says in the statement. “The FDA strongly supports advancing innovative animal biotechnology products that are safe for animals, safe for people, and achieve their intended results.”
Pigs with the genetic modification are known as GalSafe pigs and are made by Revivicor Inc, a subsidiary of the US biotech United Therapeutics. Research in the mid-2010s indicated that the knockout made transplants from the pigs less likely to be rejected by primate recipients.
See “Xenotransplant Record”
The director of the FDA’s Center for Veterinary Medicine, Steven Solomon, told reporters in a conference call yesterday that developers who want to use GalSafe pigs for therapeutic purposes will still have to seek approval for their applications. “I think that people need to be careful,” Solomon said, STAT reports. “That’s why in part, it’s going to require further evaluation for xenotransplantation, xenograft, or the other activities by the medical products centers and FDA.”
As far as food production is concerned, the statement notes that the meat is safe for consumption by the general population, adding that Revivicor “intends to sell meat from GalSafe pigs by mail order, rather than in supermarkets.”
The agency’s evaluation also concluded that GalSafe pigs presented low risk to the environment, with an impact that “is no greater than from conventional pigs.” It adds that “no animal safety concerns were noted for GalSafe pigs beyond those that would be expected in well-managed, commercial swine populations.”
Multiple other efforts to develop genetically engineered pigs are underway around the world, including some alterations designed to make pigs grow faster, and others aimed at making the animals more resistant to lethal viruses such as porcine reproductive and respiratory syndrome virus (PRRSV).