A drug made from genetically-engineered goats’ milk may be approved as a blood thinner by the US Food and Drug Administration (FDA).
The anti-clotting drug Atryn is intended to treat hereditary antithrombin deficiency, and is made by GTC Biotherapeutics from human proteins inserted into goats’ milk.
A second clot-disorder treatment, CSL’s Riastap, also appears safe and effective the FDA says, although both will need further after-market study.
The FDA is to consider a recommendation from a panel of outside advisers that both drugs are safe and effective. The agency usually accepts the the panel’s advice.
Atrynis is part of a series of anti-clotting drugs that GTC is developing and is the company’s first to be submitted for approval in the US.
Hereditary antithrombin deficiency is a condition in which excessive clotting can be caused by irregular protein levels. The treatment is made using a human protein produced in milk from genetically-engineered goats.
Traditional blood thinners such as warfarin are unsuitable for patients undergoing high-risk surgeries or giving birth. The FDA says that on balance, Atryn has an “acceptable” level of risk.
Copyright Press Association 2009