Friday, May 29, 1987

FDA Committee Reviews Activase t-PA

South San Francisco, Calif. -- May 29, 1987 --

An advisory committee of the Food and Drug Administration (FDA) met today to discuss an application by Genentech, Inc. to license Activase® tissue plasminogen activator (t-PA), a product of biotechnology being developed to treat heart attack victims.

The advisory committee heard scientists representing Genentech and the National Institutes of Health present clinical data about the use of Activase to dissolve blood clots in coronary arteries that cause heart attacks.

At the conclusion of the meeting, members of the committee indicated that Activase dissolves blood clots. But the committee asked that additional data be provided to demonstrate that by dissolving blood clots, Activase benefits heart attack victims.

After the hearing Genentech issued the following statement: "Despite our disappointment today, we remain confident that we will be able to work with the FDA to obtain approval of Activase. We will provide the FDA whatever additional data are requested; we believe much if not all of that data already are being developed"

Genentech is a leading biotechnology company, focusing on the development, manufacture and marketing of pharmaceuticals produced by recombinant DNA technology.

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