FDA approves new genetically modified pig for allergy-free medical and food products

The US Food and Drug Administration said Monday it has approved a genetically modified pig whose body doesn’t make a component that can trigger allergies in people.

The pigs should produce meat that is safe to eat, and organs and tissues safe for transplants and for the other biomedical uses for people allergic to the compound — a sugar found on the surface of animal cells known as alpha-gal, the FDA said.

It might help people who have an allergy to alpha-gal– an allergy sometimes triggered by a tick bite.

“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,” said FDA Commissioner Dr. Stephen Hahn.

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.

A company called Xenotherapeutics has three patients enrolled in a Phase 1 safety trial of using skin from GalSafe pigs for skin grafts to treat burn victims with alpha-gal allergies. The company is working to enroll three more in the trial at Massachusetts General Hospital.

“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 has approved only a few genetically modified animals — one, a genetically engineered salmon, was the only one previously approved for use as food.

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.