NoBlood

FDA Talk Paper

T03-55
July 25, 2003

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New Recombinant Antihemophilic Factor Licensed

FDA today licensed a new recombinant DNA-derived clotting factor to treat people with hemophilia A. This new antihemophilic human factor VIII product is the first one produced without using additives derived from human or animal blood in the manufacturing process.

This advancement provides added reassurance against any theoretical infectious risks that may arise from the use of blood-derived additives in the manufacturing of factor VIII.

The new product, called ADVATE Antihemophilic Factor (Recombinant), Plasma/Albumin-Free Method (rAHF-PFM), is approved to prevent and control bleeding episodes or to prepare persons with hemophilia for surgery. It is produced by genetically engineered Chinese hamster ovary cells that have been altered to produce factor VIII.

A number of human factor VIII products have been approved to treat hemophilia A, an inherited disorder in which the blood clotting protein factor VIII is deficient or abnormal. Affected persons are unable to form blood clots normally and therefore risk serious and life-threatening bleeding episodes. Replacement therapy with any of the factor VIII products, which requires intravenous administration, corrects the defect only temporarily. For this reason, factor VIII products frequently must be given several times a week, or more often, to prevent or treat bleeding episodes.

Current factor VIII products (both plasma-derived and recombinant) are considered very safe as a result of many technological advances in the last two decades. These include viral inactivation and removal steps in manufacturing that are believed to effectively prevent transmission of hepatitis B, hepatitis C or HIV from plasma-derived products. These same procedures are considered effective to minimize any infectious risks from products made by DNA technology, which uses living cells. None of these products has transmitted HIV, hepatitis B or hepatitis C since 1987.

The first recombinant antihemophilic factor was approved in 1992. However, up until now, all recombinant factor VIII products still were made with the use of blood-derived additives of human or animal origin, such as albumin. These additives were needed to keep the cells viable so they could make the factor VIII protein. In this new product non-human and non-animal materials replaced these additives.

Advate, rAHF-PFM is manufactured by Baxter Healthcare Corporation, Deerfield, Ill.

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Mr. Jan B. Wade
Blood Management Consultant
Enhance Outcomes - Control Cost
For Information Call - 360 296-1807
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