US approves drug from genetically engineered goat - February 09, 2009
Last Friday, the US Food and Drug Administration (FDA) approved its first drug produced by a genetically engineered animal. The drug, called ATryn, is produced by goats engineered to make the protein in their milk.
The approval ends a long struggle by… well several parties. The so-called “pharming” industry -- which aims to produce drugs in animals – struggled to convince investors to continue investing despite the absence of guidance on whether or how their drugs would eventually be approved. The FDA struggled to come up with a way to regulate the industry. And activists struggled to hold off the guidelines. (Europe, by the way, got its act together and approved ATryn over two years ago.)
ATryn is designated for use in patients with specific blood clotting disorders and its market will be relatively small. But although the drug itself is not likely to be a big money maker, the approval of ATryn brought a sigh of relief from pharming companies. “[It] really takes away one of the biggest issues that have always been on the table, which is how do regulatory agencies view this kind of technology,” Samir Singh of Pharming, a pharming company headquartered in Leiden, told The New York Times.
How about those investors? “Investors shrugged,” wrote Forbes' Matthew Herper in his beautifully titled blog post “Goats Make Drugs, World Doesn’t Change”. Stock in Massachusetts-based GTC Therapeutics, the company that produces ATryn, actually fell on Friday and is now trading at around $0.60 a share.
