FDA Approves Drug From Gene-Altered Goats

Boston - The Food and Drug Administration has approved Atryn and opened up a new era for the farming industry. This is the first medicine to be sold that has been made in transgenic animals. This is the first time the FDA has supported a treament made from genetically engineered animals.

Atryn is made by GTC Biotherapeutics of Framinghom, Mass. Company scientists. The approval of Atryn comes just about 1 month after the FDA panel agreed that Atryn was effective and safe in preventing life-threatening blood clots of patients who do not have normal antithrombin levels.

Atryn is made by GTC Biotherapeutics of Framingham, Mass. Company. This drug comes from goats whose DNA has been changed to make a drug that patients need with an unusual blood disorder. This is the first drug that comes from a herd of genetically engineered animals made especially to be used a living pharmaceutical factories.

Atryn is an intravenous therapy used for surgery patients or pregnant mothers who have a unusual genetic disorders that keeps their body from making enough protein, called antithrombin.

It is purified from goats’ milk whose parents have been injected with a human protein that helps to hinder blood clots. Human DNA for antithrombin and goat DNA is combined in a way so that the goat’s milk glands express hum antithrombin. FDA states that it has been their main goal to make sure the antithrombin that was produced was safe but also that the goats were not harmed in any way. The protein is produced by a herd of 200 goats that are living under conditions that are controlled and monitored very carefully on the farms.

Researchers are trying to produce drugs in animals because they can be made much faster and less expensive than a synthetic process. These farm animals are now being called ‘pharm’ animals. This way of producing can be done at lower cost and in great quantities than other methods.

Drugs have been made from animals before, but insulin mostly can from pigs or cows. And mice are now used in some drug ingredients. This is the first time a drug from a herd created to live as pharmaceutical factories.
Atryn’s use will be limited to only 100,000 patients are first but the approval of this drug marks the beginning of larges uses of genetically engineered animals in medicine.

GTC Biotherapeutics said that just one goat can make as much antithrombin in only one year that can be taken from 90,000 blood donations. It is said that if more drug is needed, the herd can be enlarged. The approval of the drug Atryn may be the first step toward new kinds of medicnes not made from just chemicals but from living organisms altered by scientists.