FDA Approves First IGA in Pigs for Food, Therapeutic Use


GalSafe pigs may potentially be used as a source of medical products, free of detectable alpha-gal sugar.


The US Food and Drug Administration (FDA) has approved Revivicor’s GalSafe pigs, a first-of-its-kind intentional genomic alteration (IGA) in domestic pigs that can be used for food or human therapeutics. 

GalSafe pigs has the potential to be utilized as a source of medical products, such as the blood-thinning drug herapin. Furthermore, these products would potentially be free of detectable alpha-gal sugar.

As such, the tissues and organ from Galsafe pigs may also address immune rejection in patients receiving xenotransplants.

"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,” said FDA Commissioner Stephen M. Hahn, MD, in a statement.

The FDA further considered that food developed from animals with IGA to be safe for consumption in the general population. Additionally, they found that using these animals had no greater impact on the US environment than from conventional pigs.

There were no noted animal safety concerns.

However, the reviewed safety data did not include information regarding elimination or prevention of food allergies. Therefore, there was no data that evaluated safety for those with alpha-gal syndrome (AGS), a recently identified type of food allergy to red meat and other products derived from mammals

As indicated by Revivicor Inc., meat from GalSafe pigs will be sold by mail order and not in the supermarket.

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