FDA Approves Pig Genomic Alteration for Human Therapeutics Use

(Bloomberg) -- The U.S. Food and Drug Administration approved a genomic alteration in pigs that could reduce potential allergic reactions when porcine materials are used for medical purposes in humans, the agency said Monday in a statement.

FDA said the intentional genomic alteration, or IGA, was the first of its kind and allows for pigs raised with it to be consumed as food and for therapeutic uses.

The alteration “is intended to eliminate alpha-gal sugar on the surface of the pigs’ cells,” the FDA said. Those with Alpha-gal syndrome (AGS) can have mild to severe allergic reactions to it in red meat such as pork, beef or lamb.

Potential uses from so-called GalSafe pigs include the blood-thinning drug heparin and in xenotransplants of tissue that may otherwise be rejected due to presence of the alpha-gal sugar, FDA said.

“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,” FDA Commissioner Stephen Hahn said in the statement.

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