Regulatory Update: FDA Approves Genetically Engineered Chicken

Written by M. Sean High – Staff Attorney

On December 8, 2015, the U.S. Food and Drug Administration (FDA) approved a genetically engineered (GE) chicken designed to produce eggs to be used in the manufacturing of a drug intended to treat the human enzyme disease lysosomal acid lipase deficiency (LAL-D).

LAL-D is a rare (and potentially fatal) disease that causes the build-up of fats within the tissue cells of multiple organs including the heart, liver, and spleen.  According to the pharmaceutical manufacturer Alexion Pharmaceuticals Inc. (Alexion), when LAL-D is present in infant patients (known as Wolman disease) there is currently a nearly 90% mortality rate; when LAL-D is present in pediatric and adult patients (known as cholesteryl ester storage disease) “with a clinical biopsy assessment, nearly 50% progress to fibrosis, cirrhosis, or liver transplant within 3 years of symptom onset.” Consequently, Alexion sought FDA approval for Kanuma, the company’s enzyme replacement therapy drug designed to combat LAL-D. 

Under Alexion’s manufacturing of Kanuma, GE chickens are raised so as to “produce a recombinant form of human lysosomal acid lipase (rhLAL) protein in their egg whites.” In turn, the rhLAL egg whites are to be purified and refined into the LAL-D fighting drug Kanuma.

FDA stated that the GE chickens and their eggs do not pose a human health risk because neither will be permitted to enter the food supply.  Importantly, FDA noted that their approval will “not cause a significant impact on the environment, because the chickens are raised in highly secure facilities.