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.
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.
Rivivicor is located in Blacksburg, Virginia.
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