US FDA approves genetically modified pigs for food, therapeutics

NEW YORK: In a major relief to a people with a recently identified type of food allergy to red meat, the US Food and Drug Administration (FDA) has approved a first-of-its-kind intentional genomic alteration (IGA) in a line of domestic pigs which may be used for both food or medical products.

The genetic alternation in these pigs, referred to as GalSafe pigs, is intended to eliminate alpha-gal sugar on the surface of the pigs' cells, the FDA said on Monday.

People with Alpha-gal syndrome (AGS) may have mild to severe allergic reactions to alpha-gal sugar found in red meat.

"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," FDA Commissioner Stephen Hahn said in a statement.

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.

Xenotransplants refers to transplantation of living cells, tissues or organs from one species to another.

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 US regulator granted approval of the IGA in GalSafe pigs to regenerative medicine company Revivicor Inc.

Alpha-gal syndrome (AGS) is a recently identified type of food allergy to red meat and other products derived from mammals.

In the US, the condition most often begins when a Lone Star tick bites someone and transmits alpha-gal sugar into the person's body.

In some people, this triggers an immune system reaction that later produces mild to severe allergic reactions to alpha-gal sugar found in red meat.