The European Medicines Agency (EMeA) have given their blessing to ATryn, an anti-blood clotting drug that contains a protein extracted from the milk of genetically engineered goats.
It is the first time EU regulatory authorities have approved a drug made from transgenic animal milk.
The ruling demonstrates the potential for some dairy firms to supply the pharmaceutical industry, and what biotechnology could be capable of in the dairy world more generally.
It is also a victory for Atryn's maker, US-based GTC Biotherapeutics, which saw the drug initially rejected by EMeA in February. The European Commission now has three months to decide if it will endorse EMeA's new decision, although an agency spokesperson said this was normally a formality.
GTC said the ruling was a significant step in unlocking the value of transgenic technology for therapeutic proteins.
Atryn contains human anti-clotting protein antithrombin alfa, normally only available to doctors from humans themselves. GTC said it inserted the human antithrombin gene into goats so that they would produce the anti-clotting protein in their milk.
It is possible the success of Atryn so far will encourage more interest in the idea of using biotechnology to place important proteins in animals' milk. Supporters say this method could save manufacturers significant costs.
"Normally if one company embraces a certain technology it is likely that others will follow," said an EMeA spokesperson to DairyReporter.com, though declining to comment on whether other companies had discussed similar drugs with EMeA officials.
It is known that some other pharmaceutical firms, such Netherlands-based Pharming NV, have examined the possibility of using milk from genetically modified animals to produce drugs.
GTC, which has made transgenic milk its speciality since it was formed in 1993, was in 2004 also reputed to be working on a cheaper malaria vaccine that would also derive from goat milk.
Ethical concerns and safety fears over the use of genetically engineered animals may be a stumbling block, however. Several campaigns groups, including Greenpeace and Friends of the Earth, have long-standing policies against genetic engineering.