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The product represents a first-of-its-kind intentional genomic alteration in a line of domestic pigs that may be used for human therapeutics.
On Dec. 14, 2020, FDA announced that it approved a first-of-its-kind intentional genomic alteration (IGA) in GalSafe pigs, a line of domestic pigs, that may be used for human therapeutics as well as food applications. The agency reported in a press release that this approval is the first IGA in an animal that it has approved for both human food consumption and as a source for potential therapeutic uses. The approval was granted to Revivicor, a US-based regenerative medicine company.
The IGA in the pigs is intended to eliminate alpha-gal sugar on the surface of the animals’ cells. Alpha-gal syndrome (AGS) occurs in people, who exhibit mild to severe allergic reactions to alpha-gal sugar found in red meat (e.g., beef, pork, and lamb). The altered GalSafe pigs may potentially provide a source of porcine-based materials for producing human medical products that are free of detectable alpha-gal sugar. For example, GalSafe pigs could potentially be used as a source of heparin, a blood thinner, allowing heparin to be produced free of detectable alpha-gal sugar. In addition, 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 agency 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. FDA determined that food from GalSafe pigs is safe for the general consumption. 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.
The agency also assessed the risk of the IGA to promote the emergence or selection of antimicrobial-resistant bacteria in or on GalSafe pigs and concluded that the microbial food safety risk is low, mitigated by the low number of GalSafe pigs entering the food supply and the ongoing surveillance for antimicrobial resistance, among other factors.
The meat from these GalSafe pigs will be supplied by mail order, rather than in supermarkets, the agency stated in its press release.
“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, MD, in the agency’s press release. “As part of our public health mission, [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.”
“[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, director of 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.”