The FDA has approved use of a genetically engineered chicken to produce an enzyme in their egg whites that will be used to treat infants and adults that produce little or none of the enzyme on their own. “The GE chickens are used only for producing the drug substance and neither the chicken nor the eggs are allowed in the food supply,” said the FDA. The chickens are raised in highly secure indoor facilities, it said.
The drug derived from the egg whites, Kanuma, is the first treatment for the rare disease lysosomal acid lipase (LAL) deficiency, which affects 26 or 27 individuals per 1 million births. People with little or no LAL enzyme activity suffer a build-up of fats within the cells of various tissues that can lead to liver and cardiovascular disease, said the FDA. The egg whites of the GE chickens are refined to extract a recombinant version of the human LAL protein that eventually produces Kanuma. “Using this technology, these patients for the first time ever have access to a treatment that may improve their lives and chances of survival,” said Dr Janet Woodcock, director of FDA’s WoodcockCenter for Drug Evaluation and Research, which approve Kanuma.