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FDA issues first dual food-therapy IGA for alpha-gal-free pigs

Posted 14 December 2020 | By Kari Oakes 

FDA issues first dual food-therapy IGA for alpha-gal-free pigs

A new line of domestic pigs has been genetically altered so that their cell surfaces do not carry a type of sugar that can cause severe reactions when the meat is consumed or porcine-derived therapies or devices are introduced into people with the allergy.
The US Food and Drug Administration (FDA) today approved the intentional generic alteration (IGA) of the pigs, called GalSafe pigs because the potentially allergenic sugar is called alpha-gal sugar. The approval, given to Revivicor Inc., represents the first time that FDA has approved an IGA for both human food consumption and for potential human therapeutics.
“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 Stephen Hahn, MD.
Therapeutic applications for porcine material include heparin, porcine heart valves and other xenografts such as skin and tendons.
Some individuals develop an allergy to alpha-gal sugar after bites from the Lone Star tick, meaning that eating both beef and pork can trigger a delayed, but sometimes severe, allergic reaction. However, it is thought that alpha-gal sugar can also more generally be a cause of rejection of xenotransplants.
The sponsor, said FDA officials in a press call on 14 December, did not seek a specific claim for consumption of GalSafe pigs for individuals with alpha-gal allergy. FDA has determined only that GalSafe meat is safe for the general population to eat and that several generations of GalSafe pigs did not have detectable alpha-gal sugar.
“It’s important to note that these pigs have not been evaluated for use as xenotransplantation products for transplantation or implantation into human subjects,” clarified FDA in the press release announcing the IGA for GalSafe pigs. “Developers of any such human medical products must first submit an application to, and obtain approval from, the FDA before these products can be used in human medicine.”
The work done to study GalSafe pigs was conducted through the Veterinary Innovation Program, which encourages “development and research of innovative public health products, as well as supporting an efficient and predictable pathway to the approval of IGAs in animals,” said Steven M. Solomon, DVM., director of FDA’s Center for Veterinary Medicine.
This is the fourth IGA granted by FDA; three of the prior IGAs have been for biopharmaceutical applications, and one for a genetically engineered line of farmed Atlantic salmon.


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Tags: FDA, US

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