Genetically modified pig for allergy-free medical and food products approved by FDA

The pigs, licensed to Revivicor Inc., a subsidiary of United Therapeutics, are called GalSafe pigs. Revivicor is a spinoff from PPL Therapeutics, which produced the first mammal cloned from an adult mammal: Dolly the sheep, in 1996.

Products made from their bodies can be safely used by people with alpha-gal syndrome, FDA officials told a media briefing. These might include the blood thinner heparin, made from pig intestines, as well as tissue or organ transplants.

“In the U.S., 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,” the agency said in a statement.

The FDA did a toxicology review. “We have examined this and this is a product that is safe for general populations, human food production,” Dr. Steven Solomon, director of the FDA’s Center for Veterinary Medicine, told reporters.

In 2009, the FDA approved the first product made by genetically engineered animals — an anticoagulant used for the prevention of blood clots in patients with a rare disease known as hereditary antithrombin deficiency. The product, known as ATryn, is made using the milk of genetically modified goats.

There’s also a therapy called Kanuma that’s made from the eggs of genetically engineered chickens and used to treat people with a rare protein deficiency and a product called Sevenfact made in the milk of genetically modified rabbits used to treat a certain form of hemophilia.