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FDA Panel Gives Blessing to First Drug Manufactured in Bioengineered Goats
The first drug ever manufactured in genetically-modified animals is likely coming soon to the U.S. market. A panel of expert advisers to the FDA said today that an experimental anti-clotting product developed by Framingham, MA-based GTC Biotherapeutics looks safe and effective enough to become a marketed product.
The advisers essentially agreed with the conclusions reached by FDA staff, based on documents that were made publicly available Wednesday morning. The FDA still hasn’t made a final decision; its deadline for doing so is Feb. 7.
The product in question, a human protein called antithrombin, is isolated from the milk of goats who have been genetically modified to produce copious amounts of the protein. The drug, marketed as ATryn, has been cleared for sale in Europe since 2006. It hasn’t been a financial boon for GTC, but the company hopes that winning this FDA panel blessing will set a precedent that its manufacturing method, sometimes called “pharming,” can be used for other, more profitable medicines. GTC has signed a partnership with Deerfield, IL-based Ovation Pharmaceuticals who will now gear up in hopes of marketing the drug.
“We are very pleased with the Advisory Committee’s recommendation,” said Geoffrey Cox, CEO of GTC Biotherapeutics, in a statement after the panel’s recommendation.
Pharming’s appeal, as David Stipp wrote for us back in February, comes from its ability to churn out large quantities of protein drugs in a cheap way. Scientists already know how to make genetically engineered protein drugs through fermentation-style techniques using standard lab organisms like E. coli, yeast, or hamster cells, although these methods are more costly and time-consuming than milking a goat.
GTC was able to successfully point out that all protein drugs have to go through a rigorous purification process to separate the drug from all the gunk it brews with. Since they proved the end product is pure and consistent, who cares if it came from a modified goat?