The U.S. Food and Drug Administration said on Monday it had approved a genetically modified pig that does not cause any allergies. The new type of swine would be free of the alpha-gal sugar (which causes allergies in certain people) and would be used in food and medical applications.
“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.
“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 new pigs are referred to as GalSafe pigs and could, for example, potentially be used to create the blood-thinning drug heparin, free of detectable alpha-gal sugar. The pigs' tissues and organs could also potentially be used to address the issue of immune rejection (believed to be caused by alpha-gal sugar) in patients receiving xenotransplants.
“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 FDA also revealed that the potential environmental impact of the new GalSafe pigs on the U.S. would be no greater than that of conventional pigs and that no animal safety concerns would arise other than those expected in commercial swine operations.