Friday, Nov 13, 1987
South San Francisco, Calif. -- November 13, 1987 --Genentech, Inc., announced today that the Food and Drug Administration (FDA) has licensed Activase ®(Alteplase, recombinant), a major new product of biotechnology, for the treatment of heart attacks. When administered to a heart attack victim, Activase dissolves clots obstructing coronary arteries, improves ventricular function and reduces the incidence of congestive heart failure.
Activase, a tissue plasminogen activator (t-PA), is a safe and effective blood-clot dissolving agent. At least 80 percent of the 1.5 million heart attacks suffered by Americans each year occur when blood clots form in coronary arteries, blocking blood flow to the heart. Activase works by dissolving the blood clots that develop in these arteries.
Activase is most beneficial when administered early in the course of a heart attack so that blood flow to the heart is restored before permanent damage to the heart muscle has occurred. Therefore, its availability now makes it critical for patients to get early emergency treatment when the symptoms of a heart attack occur. "The average patient with an evolving heart attack does not seek medical attention for several hours," reported Burton E. Sobel, M.D., Professor of Medicine, Washington University, St. Louis, and a leading expert in cardiovascular disease. "With the availability of Activase it is essential that patients seek medical attention immediately if symptoms of a heart attack occur."
"We believe that Activase offers new hope in the treatment of heart disease, the nation's number one killer," said Robert A. Swanson, Genentech chief executive officer. "The approval of Activase confirms the promise of biotechnology. It's very exciting for me to see this dream become a reality."
Activase is a form of tissue plasminogen activator, or t-PA, an enzyme that is produced naturally by the body to dissolve blood clots, but in amounts too small to quickly dissolve clots in coronary arteries. Through recombinant DNA technology, or genetic engineering, Genentech can produce Activase in sufficient quantity for therapeutic use.
Activase is administered intravenously, and when it enters the bloodstream its activity is enhanced when it comes in contact with a blood clot. It triggers the body's own clot-dissolving mechanism in the immediate vicinity, dissolving the clot and restoring blood flow, thereby helping to salvage the endangered heart muscle. Activase dissolves most blood clots in approximately 45 minutes.Activase is the first blood clot dissolving agent that is relatively fibrin specific (or clot selective). Fibrin is the material of which clots are composed.
Clinical testing of t-PA began in February 1984. Activase has been tested in more than 3,700 patients in over 100 medical centers worldwide. In two separate clinical studies, Activase was shown to improve heart function after a heart attack.
A study of heart function conducted at Johns Hopkins Medical Institutes in Baltimore showed that Activase, compared with placebo, significantly improved ventricular function (the heart muscle's ability to pump blood) and reduced the incidence of congestive heart failure which results from poor heart muscle performance. Activase is the only agent on the market which is indicated for the reduction of the incidence of congestive heart failure following a heart attack.
Another placebo-controlled study conducted in Sydney, Australia, also confirmed improved ventricular function in patients given Activase, again showing limitation of heart muscle damage.
The extensive clinical research proved that clots were dissolved consistently in more than 70 percent of heart attack patients, restoring critical blood flow to endangered heart muscle.
The Product License Application for Activase was submitted by Genentech to the FDA in April 1986. On May 29, 1987, the Cardio-Renal Advisory Committee recommended that the FDA request additional information. Since then, Genentech has worked closely with the FDA in making such information available, which has resulted in today's approval.
Activase can be used in the great majority of patients having heart attacks. However, the attending physician must weigh benefits and risks and determine who is an appropriate candidate for therapy.
Activase's ability to dissolve blood clots means that it can also cause bleeding which is primarily minor and easily controlled. While infrequent, there is a small risk of bleeding that cannot be easily controlled. In clinical trials, at the recommended dose, intracranial bleeding occurred in less than one-half of one percent (i.e. 0.4%) of patients. Therefore, Activase is not recommended for use in patients at high risk of hemorrhage or with a history of stroke; or in patients with a bleeding disorder, active internal bleeding, recent surgery or major injury, or severe, uncontrolled high blood pressure.
"Genentech is committed to extensive professional medical information programs to ensure that physicians and nurses are well informed about the proper use of Activase in the treatment of heart attacks," said Ralph Snyderman, M.D., Genentech vice president of medical research and development. "These programs will make available to all health professionals the experiences of the physicians who have treated thousands of patients with Activase."
Shipments of Activase will begin in two to three weeks, and will be available for administration in hospital emergency rooms and cardiac care units.
Genentech, Inc., founded in 1976 and based in South San Francisco, California, is a leading biotechnology company focusing on the development, manufacture and marketing of recombinant products for human health care. Four out of five approved therapies derived from biotechnology were pioneered by Genentech including human insulin, a treatment for diabetes; and alpha interferon for treating a form of leukemia. The company markets Protropin® (somatrem for injection), a human growth hormone for the treatment of children suffering from growth hormone deficiency.
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