The company Xenotherapeutics is using GalSafe pigs in three trials for skin transplants for burn victims who have Alpha-gal syndrome and plans to conduct three more at Massachusetts General Hospital.
"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 M. Hahn, M.D.
As part of its review, the FDA evaluated the safety of the IGA for the animals and people eating meat from them, as well as the product developer's intention to market the IGA for its ability to eliminate alpha-gal sugar on pigs' cells. The name stems from them lacking the alpha-gal sugar molecule, which is found in many mammals, except humans. People with Alpha-gal syndrome (AGS) may have mild to severe allergic reactions to alpha-gal sugar found in red meat (eg, beef, pork and lamb).More news: Criticism over use of 'Dr' title by Biden's wife sparks outrage
The Food and Drug Administration gave approval this week to pigs that have been engineered to cut out "alpha-gal" sugar in their cells that can cause severe allergic reactions in humans if eaten.
The US Center for Food Safety, a non-profit organisation, noted that the meat from the genetically-modified pigs had not yet been tested on people with the allergies. In medicine, the pigs' intestines can be used for making the blood-thinning drug Heparin.
The FDA determined that the domestic line of "GalSafe" pigs are safe to eat and said the absence of alpha-gal sugar in their tissues and organs would lead to lower rejection rates in patients receiving xenotransplants. The AGS causes serious meat allergy that can happen after a deer tick or lone star bite.
Pigs have always been used for tissue and organ transplants, but for those allergic to alpha-gal sugar the transplant is typically rejected by the body.More news: Former Ravens RB Lorenzo Taliaferro dies at 28
FDA said the intentional genomic adjustment, or IGA, was the first of its kind and allows for pigs raised with it to be consumed as food and for therapeutic uses.
"Only one other similarly engineered animal â€" a genetically modified salmon â€" has been approved by the FDA for human consumption.
In the past few years, meat alternatives, both plant-based and genetically modified, have hit the mainstream.
The therapy with the milk is called ATryn and is administered to those with a rare disease called hereditary antithrombin deficiency. Another therapy known as Kanuma, which is used to treat patients with a rare protein deficiency, is made with eggs from genetically modified chickens.More news: Star Wars Boba Fett actor Jeremy Bulloch dies aged 75