HHS News Release - March 1, 1993
U.S Department of Health and Human Services, Food and Drug Administration

The following can be used to answer questions.

Hemophilia A is an inherited disorder in which the blood of affected persons is unable to form clots due to a missing or deficient blood clotting protein factor VIII. Affected persons must often be treated daily by intravenous infusion with the reconstituted factor. This antihemophilic factor is produced by baby hamster kidney cells that have been altered by recombinant DNA technology to produce factor VIII.

In the past, some factor VIII concentrates from human plasma resulted in the transmission of hepatitis and AIDS to patients, but all antihemophilic factor concentrates currently licensed in the United States are now manufactured in ways that are believed to eliminate the risk of transmission of these viruses. The recombinant DNA technology eliminates even a theoretical possibility of the transmission of viruses from plasma.

The first antihemophilic factor (recombinant), Recombinate, was licensed on December 10, 1992.

On December 12 and 13, 1991, FDA's Blood Products Advisory Committee, a group of outside experts, met and recommended approval of the product approved on February 25, 1993, following a review of data from three clinical trials that had been conducted both with patients who had been exposed to blood or blood products and with patients who had not.

The new antihemophilic factor (recombinant) is manufactured by Miles Inc., Elkhart, Ind. It will be sold under the brand name Kogenate.