8 December

2015 – The US Food and Drug Administration has approved genetically engineered chickens that produce the drug called “Kanuma” in the egg albumen. The recombinant human enzyme, in this case the drug “Kanuma” is approved to treat people with a rare genetic disorder lysosomal acid lipase deficiency. The disorder is characterized by faulty fatty acid metabolism that accumulate in the liver, spleen and the vascular system. While the disorder is fatal for children, in elderly patients it causes liver enlargement, fibrosis and cirrhosis, as well as cardiovascular disease. (2)

Kanuma, or the active enzyme must be separated from the egg albumen. The drug is marketed by the Alexion Pharmaceuticals company. (2)

Since all the cells in the genetically modified chickens contain modified DNA these chickens and their eggs are not approved for human consumption. (2) In the approval process the FDA took into account whether the modified DNA can damage chickens, whether it is stable, and whether it is transferred to the next generation of chickens. The FDA claims that the chickens can not inadvertently enter the human food chain and that they do not pose a negative impact on the environment because they are kept indoors. (1,2)

This is the third type of GM animals approved for drug production by the American FDA. FDA approved GM goats in 2009 that produce a drug that prevents blood clots, and in 2014 approved GM rabbits that produce the drug called “Ruconest” in milk. (1)

Sources:
1. Arielle Duhaime-Ross: FDA approves genetically modified chicken – but not as food. The Verge. 09 December 2015, theverge.com.
2. Rachel Becker: US government approves transgenic chicken. Nature, 09 December 2015., nature.com.