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FDA approves first IGA in GalSafe pigs for human food, promising therapeutic uses

FDA approves first IGA in GalSafe pigs for human food, promising therapeutic uses Today, the U.S. Food and Drug Administration approved a first-of-its-kind intentional genomic alteration (IGA) in a line of domestic pigs, referred to as GalSafe pigs, which may be used for food or human therapeutics. This is the first IGA in an animal that the FDA has approved for both human food consumption and as a source for potential therapeutic uses. 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 mild to severe allergic reactions to alpha-gal sugar found in red meat (e.g., beef, pork, and lamb).

FDA Approves First-of-its-Kind Intentional Genomic Alteration in Line of Domestic Pigs for Both Human Food, Potential Therapeutic Uses

December 14, 2020 Today, the U.S. Food and Drug Administration approved a first-of-its-kind intentional genomic alteration (IGA) in a line of domestic pigs, referred to as GalSafe pigs, which may be used for food or human therapeutics. This is the first IGA in an animal that the FDA has approved for both human food consumption and as a source for potential therapeutic uses. 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 mild to severe allergic reactions to alpha-gal sugar found in red meat (e.g., beef, pork, and lamb). 

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