December 28, 2020

Genetically Modified Pigs Approved by FDA for Biomedicine and Food

Genetically Modified Pigs Approved by FDA for Biomedicine and Food

The United States Food and Drug Administration (FDA) announced the approval for a genetically modified line of pigs for biomedicine and food. The GalSafe pigs, by Revivicor Inc., eliminate the 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, and typically begins by a Lone Star tick bite. This is the first time approval has been granted for both purposes concurrently.

“Today’s first-ever approval of an animal biotechnology product for both food and as a potential source for biomedical use represents a tremendous milestone for scientific innovation,” said FDA Commissioner Stephen M. Hahn, M.D. in a press release. “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. Today’s action underscores the success of the FDA in modernizing our scientific processes to optimize a risk-based approach that advances cutting-edge innovations in which consumers can have confidence.”

The FDA analyzed the potential impact that the approval of the GalSafe pigs would have on the United States environment and determined it would be no different than conventional pigs. The FDA also examined the risk of antimicrobial-resistant bacteria of human health in or on the GalSafe pigs, concluding the risk is low and alleviated by the low number of GalSafe pigs entering the food supply. The FDA will continue ongoing surveillance of these issues.

GalSafe pigs could work as various therapeutics in humans, such as being used as a source of medical products, like the blood-thinning drug heparin, free of detectable alpha-gal sugar. 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, but these pigs have not been assessed for use as xenotransplantation products for transplantation or implantation into human subjects. The FDA also concluded that the GalSafe pigs are safe for the general population to consume. With this being said, the FDA only evaluated Revivicor’s claims that the GalSafe pigs are free of alpha-gal sugar and safe to eat, but Revivivor did not provide data or make claims relating to food allergies, therefore the FDA did not evaluate the food safety related to those with AGS.

“The FDA is committed to continuing its close work with developers to facilitate safe advancements of animal biotechnology. Our Veterinary Innovation Program focuses on providing greater certainty in the regulatory process, encouraging development and research of innovative public health products, as well as supporting an efficient and predictable pathway to the approval of IGAs in animals,” said Steven M. Solomon, D.V.M., M.P.H., director of the FDA’s Center for Veterinary Medicine. “The developer of GalSafe pigs participated in this program, proving the impact of this important FDA initiative. We look forward to continued work with other developers to evaluate the safety and effectiveness of additional innovative animal biotechnology products.”