First Genetically Modified Pharmaceutical Receives FDA Approval
The FDA has just made history by approving the first pharmaceutical drug available for use in humans derived from genetically modified ingredients. Approval of the drug may also make it easier for other genetically modified pharmaceuticals to gain approval in the near future, ramping up greater concern over the already contentious genetically modified ingredients found in nearly 80 percent of all processed food sold in the U.S.
Called Elelyso, the drug distributed by Pfizer Inc. is targeted at treating an extremely rare disorder called Gaucher disease where sufferers lack a specific enzyme and can experience liver and neurological disorders as a result of a dangerous buildup of fatty chemicals that can accumulate in the liver, bones, spleen and nervous system. Gaucher disease affects roughly only 6,000 people in the US. The drug is reported to ease many of the symptoms for the sufferers. It does also come with its own risks and side effects including headache, chest pain, fatigue, skin irritations, joint pain and flushing.
Protalix BioTherapeutics developed the drug for Pfizer by creating the human enzyme in the cells of carrots. This was done by the insertion of a gene that encodes the protein into the carrot’s cells.
While Elelyso is the first genetically modified pharmaceutical to hit the market, it is not the first to be produced. According to Nature.com, “In 2006, the US Department of Agriculture approved of a chicken vaccine produced in plant cells. But assuaging concerns about plant-derived biologics for human use has proved much more difficult.”
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