Monday, Feb 27, 1989
South San Francisco, Calif. -- February 27, 1989 --Genentech, Inc. today announced that the Food and Drug Administration (FDA) has approved its claim that tissue plasminogen activator (t-PA), its heart attack drug, saves lives. The FDA approval letter is dated February 23. The reduced mortality indication is added to the current labeling for the product, which is sold under the brand name Activase. Original indications were for dissolving clots in coronary arteries, improving left ventricular function and reducing the incidence of congestive heart failure following heart attacks.
"Despite widespread belief within the medical community that Activase does indeed save lives, we had been prevented from proactively marketing the life-saving benefits of Activase to physicians," said James M. Gower, senior vice president of marketing. "With this approval, we can effectively communicate the key benefit of Activase--namely, it saves heart attack patients' lives."
Approval of a mortality claim for Activase is based on data from two studies demonstrating improved survival following a heart attack when Activase was compared to a placebo. The primary study on which the FDA based its approval of the reduced mortality claim is the Anglo-Scandanavian Study of Early Thrombosis (ASSET). In this trial, mortality was reduced by one-quarter, from 9.8 percent in placebo-treated patients compared to 7.2 percent in patients treated with Activase within five hours.
In a second, supporting study, the European Cooperative Study Group (ECSG) trial, Activase administration within five hours of symptom onset significantly reduced mortality at 21 days from 6.3 percent to 3.7 percent. Treatment with Activase within three hours of symptom onset resulted in 68 percent fewer deaths at 21 days.
"Activase's impact on mortality has most recently been supported by the landmark Thrombolysis in Myocardial Infarction (TIMI) trial, Phase II, conducted by the National Institutes of Health," according to Barry M. Sherman, M.D., Genentech director of clinical research. "Activase, in conjunction with conservative patient management, resulted in a six-week mortality rate of 4.7 percent, the lowest ever reported in a large scale United States thrombolytic trial." TIMI-II was not part of Genentech's FDA submission for the Activase mortality claim.
Activase, which received FDA approval in November 1987, was one of the most successful new drugs launched in the United States, generating sales of approximately $190 million in its first 12 months on the market. Activase holds about two-thirds of the U.S. market for thrombolytic therapy.
Genentech, Inc., is a biotechnology company focusing on the development, manufacture and marketing of pharmaceutical products produced by recombinant DNA technology.
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