For the first time, the Food and Drug Administration approved for food and human therapeutics on Monday a genomic alteration in domestic pigs that prevents them from producing a sugar that can cause allergic reactions in some people. “A tremendous milestone for scientific innovation,” said FDA commissioner Stephen Hahn.
The intentional genomic alteration (IGA) in the so-called GalSafe pigs is intended to eliminate alpha-gal sugar on the surface of pig cells. People with Alpha-gal syndrome may have mild to severe allergic reactions to the sugar found in red meat. Also called red-meat allergy, Alpha-gal syndrome may be triggered by bites from the lone star or black-legged tick and can be life-threatening, says the CDC. Most of the reported cases are among people living in the U.S. Southeast.
Until now, the only genetically modified animal approved by the FDA for human consumption was the fast-growing AquAdvantage salmon from AquaBounty.
Revivicor Inc, the developer of the IGA, plans to sell meat from GalSafe pigs by mail order rather than in supermarkets, said the FDA. Based in Blacksburg, Virginia, Revivicor is a spin-off of the British company that produced Dolly the sheep, the world’s first cloned animal, and later cloned pigs. The company is a subsidiary of United Therapeutics Corp.
Potentially, GalSafe pigs could provide a source of porcine materials to produce human medical products that are free of alpha-gal sugar, said the FDA. The products might be used in making a version of the blood-thinning drug heparin or tissues or organs for transplants that are free of detectable alpha-gal sugar. The sugar is believed to be a cause of transplant rejection by humans.
Before approving the IGA, the FDA determined that meat from the pigs was safe for the general population to eat and that the alteration did not harm the pigs. The agency said it also checked to see there were no detectable levels of alha-gal sugar after multiple generations of the pigs.
“The FDA is committed to continuing its close work with developers to facilitate safe advancements of animal biotechnology,” said Steven Solomon, director of FDA’s Center for Veterinary Medicine. Revivicor took part in an FDA program for animal biotechnology developers.
Because Revivicor did not submit data on food allergies, the FDA said it did not evaluate safety specific to people with Alpha-gal Syndrome, which was discovered comparatively recently.
An FDA question-and-answer on regulation of IGAs is available here.
An FDA description of its Veterinary Innovation Program involving IGAs is available here.