January 8, 2009
Newest Anti-Clotting Drug Made From Goat’s Milk?
Does your family have a history of blood clots? If you do, the good news is that the newest anti-clotting medication is moving closer to distribution in the US. The interesting and unusual thing about the drug is that that is made from"¦. goat's milk.
The scientific first, the drug, prepared from the milk of genetically engineered goats received approval from the experts at the Food and Drug Administration. The FDA has announced that the medication is effective and safe.
Named ATryn, the drug is meant to aid those suffering from an unusual hereditary disorder that caused accelerated vulnerability to blood clots.
The medicine's authorization would be a huge step toward innovative medications made from active organisms genetically altered by scientists. Related drugs could become accessible in the next following years for a variety of problems, including hemophilia.
A Massachusetts biotechnology corporation, GTC Biotherapeutics, created ATryn by shifting around the genes of goats so they would make milk loaded with antithrombin, a protein that in performs like a natural blood thinner.
1 in 5,000 individuals do not make antithrombin, which raises the risk of developing blood clots. These clots can be painful, and if move into the bloodstream, lungs or brain, the results can be deadly. Pregnant women affected with the disorder are more likely to miscarriage or have a stillbirth, due to clots in the placenta.
Karen Janes, who lost her teen daughter Mary Karen from a brain clot connected to the disorder, says the important thing is that the drug is effective, not that it is made from goat's milk.
"I think this goat thing is just wonderful," said Janes. "I do want this drug to go through all the rigors of testing by the FDA. But if it can work, and it can save other families from what we went through, I think that's marvelous."
The FDA will consider the hazards and benefits of ATryn at a meeting on Friday, and make a proposal to, or not to, approve the medicine.
"It's the first time we've held an advisory committee meeting on any product from a genetically engineered animal," said FDA spokeswoman Siobhan DeLancey.
If the drug passes the tests, the FDA could call for additional monitoring to ensure that patients' immune systems avoid creating antibodies in response to the medicine.
"I think this is an important tipping point," said Geoffrey Cox, chairman of GTC, the drug maker. "The real dramatic thing that is happening here is that we've been able to reduce some very clever science to the practical level of producing a drug that's safe and efficacious. Those things aren't trivial."
In the past, antithrombin was manufactured from blood products harvested from human donors. Creating the goat protein could be healthier for humans, stated Dr. Stephan Moll, a hematologist at the University of North Carolina. It would guarantee a continual supply and lessen worries about infection.
"It's a new mechanism by which drugs could be produced in pretty large volume in the future," said Moll.
ATryn is already on the market in Europe.
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