The FDA yesterday approved for the first time a drug made in genetically-modified animals – Atryn.
The drug that was approved for sale is made from goats that have altered DNA that enables them to produce a drug very useful for patients suffering from a rare blood disorder. The milk of the goats with modified DNA contains protein called antihrombin, which is sometimes in short supply because of few human plasma donations.
According to data provided by GTC Biotherapeutics, one of its goats can produce in a year as much protein as can be derived from 90,000 blood donations. And if more drug is needed, “you breed more,” said Thomas Newberry, a spokesman of the Framingham, Mass.-based company.
It is certainly not the first case of drugs derived from animals. Most insulin used for diabetes comes from pigs and cows, while some drugs are obtained from genetically-engineered mice.
However, the FDA’s decision is a first because it allows companies to sell drugs obtained from animals created purposely to serve as living pharmaceutical factories. This will certainly not end here and the decision will surely stir reactions from numerous environmental advocates and animal rights groups.
The Humane Society of the United States already reacted to the FDA decision. The institution described the method of obtaining the aforementioned protein as “a mechanistic use of animals,” which are used as “tools” for human rather than “sentient creatures.”
ATryn is used to untangle blood clots in patients who lack sufficient quantities of antithrombin. The drug would be given in hospital settings to people who lack the aforementioned protein because they are at a high risk during surgeries and childbirth.
The scientists working for GTC Biotherapeutics successfully combined human DNA for antithrombin with goat DNA sot that the goat's milk glands would express human antithrombin.
“It is novel and has great potential for where we can go with this new technology," said Bernadette Dunham, head of FDA's Center for Veterinary Medicine.
