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Published on 8 January 2009

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Blood-thinning drug may be approved

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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

Atryn



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