Monday, Apr 3, 1995
South San Francisco, Calif. -- April 3, 1995 --Genentech, Inc. (NYSE: GNE) announced today that the accelerated infusion regimen of the company's clot-dissolving heart attack drug, Activase® (Alteplase, recombinant), a genetically engineered version of the naturally occurring tissue plasminogen activator (t-PA), was cleared for marketing for the management of acute myocardial infarction (AMI) by the U.S. Food and Drug Administration (FDA).
The product's revised labeling incorporates data from the worldwide GUSTO* trial, which showed that the new regimen was superior compared to another clot- dissolving agent in that significantly fewer patients died -- 10 per every 1,000 treated -- who received the accelerated infusion regimen of Activase than those who received a standard dose of Kabikinase, a brand of Streptokinase.
In the GUSTO study, Activase was administered more rapidly -- over 90 minutes rather than three hours, the currently marketed regimen. These two Activase dosing regimens were not compared and both will be included in the revised label.
The raw data from the 41,000-patient study was provided to the FDA on CD-ROM to facilitate its independent review. "The FDA has reviewed and accepted the principal GUSTO findings, which is good news for heart attack patients and their families," said G. Kirk Raab, Genentech's president and chief executive officer. "Now, because these important findings are incorporated into the drug's labeling, more physicians are likely to apply this new, life-saving regimen in AMI care."
About 170,000 heart attack patients received clot-dissolving therapy in 1994. About 70 percent of those received Activase® (Alteplase, recombinant). More Alteplase is also being used in Canada, Europe and elsewhere in the world.
GUSTO, the largest heart attack study ever conducted, was designed to compare the mortality rates associated with several thrombolytic, or clot-dissolving, regimens. All patients in GUSTO received heparin and aspirin. The results showed that patients receiving the accelerated regimen of Activase were less likely to die compared to patients receiving the standard dose Kabikinase regimens tested in the trial. Although the overall stroke rates, including hemorrhagic stroke, were higher among those patients receiving the accelerated infusion regimen of Activase, there were still significantly fewer total deaths or nonfatal strokes among these patients -- nine fewer per every 1,000 treated -- than those treated with the standard Kabikinase dose.
The revised label states that "subgroup analysis of patients by age, infarct location, time from symptom onset to thrombolytic treatment, and treatment in the U.S. or elsewhere showed consistently lower 30-day mortality for the group treated with the accelerated infusion regimen of Activase."
Time is a crucial factor in the identification and treatment of AMI patients. Heart attack treatment guidelines from the National Institutes of Health's National Heart Attack Alert Program strongly recommend treatment as soon as possible after the initial symptoms of a heart attack to save more lives and improve outcomes.
"To help hospital emergency departments achieve these goals, Genentech is committed to actively supporting the medical community's efforts to administer prompt, life-saving care to all those eligible to receive it," said Raab.
Activase will continue to be covered under Genentech's existing Activase Financial Assistance Program so that patients who are uninsured and can not otherwise afford to pay for it can receive it.
Genentech, Inc. is a leading, international biotechnology company that discovers, develops, manufactures and markets human pharmaceuticals for significant unmet medical needs. The company has headquarters in South San Francisco, California, and is traded on the New York and Pacific Stock Exchanges under the symbol GNE.
* Global Utilization of Streptokinase and t-PA for Occluded Coronary Arteries
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