FDA approves intentional genomic alteration in pigs

The U.S. Food and Drug Administration has approved an intentional genomic alteration line of domestic pigs which may be used as food or for human therapeutics.

Pig who is represented on a white background
Tsekhmister | Bigstock.com

Line of domestic pigs eliminates alpha-gal sugar, may be used in human food and for potential therapeutic uses

The U.S. Food and Drug Administration (FDA) has approved an intentional genomic alteration (IGA) line of domestic pigs which may be used as food or for human therapeutics.

The FDA granted the approval – the first of its kind – to biotech firm Revivicor Inc. for its GalSafe pigs. According to an FDA news release, the IGA in GalSafe pigs is intended to eliminate alpha-gal sugar on the surface of the pigs’ cells. People with alpha-gal syndrome (AGS) may have an allergic reaction to alpha-gal sugar found in meat from pigs, cattle and lamb.

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.

“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 in the news release.

The FDA also analyzed the potential impact that the approval of the IGA in GalSafe pigs would have on the U.S. environment and determined it is no greater than from conventional pigs. The conditions under which GalSafe pigs will be kept are far more stringent than those for conventionally farmed pigs. Additionally, no animal safety concerns were noted for GalSafe pigs beyond those that would be expected in well-managed, commercial swine operations.

Additionally, the FDA assessed the risk of the IGA to promote the emergence or selection of antimicrobial-resistant bacteria of human health concern in or on GalSafe pigs. The FDA concluded that the microbial food safety risk is low and is mitigated by the low number of GalSafe pigs entering the food supply and the ongoing surveillance for antimicrobial resistance, among other factors.

GalSafe pigs may potentially provide a source of porcine-based materials to produce human medical products that are free of detectable alpha-gal sugar, FDA said. 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.

Revivicor indicated that it initially intends to sell meat from GalSafe pigs by mail order, rather than in supermarkets.

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