Earlier this week, the Food and Drug Administration (FDA) approved the first of its kind intentional genomic alteration (IGA) in a line of pigs known as GalSafe pigs. The line of pigs has been genetically altered to eliminate the galactose-alpha-1,3-galactose sugar — more commonly known as alpha-gal — from the surface of the cells.
The rate of alpha-gal syndrome — a condition whereby the body develops an allergic reaction to the alpha-gal sugar commonly found in mammalian meat such as beef, pork, and lamb — has skyrocketed across the country. The disease is transmitted via the bite of the lone star tick whose habitat has been expanding due to global warming.
Said Dr Stephen M Hahn, FDA Commissioner:
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. 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.
GalSafe pigs may potentially provide a source of porcine-based materials to produce human medical products that are free of detectable alpha-gal sugar. For example, GalSafe pigs could potentially be used as a source of medical products, such as 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.
As part of its review, the FDA evaluated the safety of the IGA for the animals and people eating meat from them, as well as the product developer’s intention to market the IGA for its ability to eliminate alpha-gal sugar on pigs’ cells. The FDA determined that food from GalSafe pigs is safe for the general population to eat. The FDA’s review also focused on ensuring the effectiveness of the IGA through the evaluation of data demonstrating that there is no detectable level of alpha-gal sugar across multiple generations of GalSafe pigs.
Stated Dr Steven M Solomon, Director of the FDA’s Center for Veterinary Medicine:
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. 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.
It’s important to note that these pigs have not been evaluated for use as xenotransplantation products for transplantation or implantation into 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.
Click here for our full coverage of alpha-gal syndrome.
Q&A: Everything You Need to Know About Alpha-gal Syndrome, the Meat Allergy You Can ‘Catch’