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FDA Approves TNKase

FDA Approves TNKase (tenecteplase) for Treatment of Heart Attack

SOUTH SAN FRANCISCO, Calif., June 2, 2000 -- Genentech, Inc. (NYSE: DNA) announced today that TNKase™ (Tenecteplase), its new, single-bolus thrombolytic agent, which holds the potential to simplify heart attack treatment, has been approved by the U.S. Food and Drug Administration for the treatment of acute myocardial infarction (AMI). TNKase is the first "clot-buster" that can be administered over five seconds in a single dose, offering physicians the fastest administration of a thrombolytic to date in the treatment of heart attack.

"TNKase represents an important advance in the speed with which heart attack treatment can be delivered to patients, offering physicians the most rapid administration available to date with a new, safe and effective therapeutic option," said Arthur D. Levinson, Ph.D., Genentech chairman and chief executive officer.

ASSENT 2 (ASsessment of the Safety and Efficacy of a New Thrombolytic agent) – the 17,000-patient, pivotal trial on which today's approval primarily is based – compared a weight-adjusted dose of TNKase with the approved 90-minute accelerated infusion of Activase®‚ (Alteplase, recombinant), the most widely-used thrombolytic during the past decade. TNKase was dosed in a weight-tiered fashion ranging from 30-50 mg based on actual or estimated weight.

"The introduction of TNKase has the potential to significantly impact how heart attack patients are now treated due to the speed and ease with which it can be administered," said Christopher Granger, MD, FACC, associate professor of medicine and director of the cardiac care unit at Duke University Medical Center in Durham, NC, and lead U.S. investigator for ASSENT 2.

ASSENT 2 yielded the following mortality rates: TNKase (Tenecteplase), 6.2 percent (n=8461); Activase‚ (Alteplase, recombinant), 6.2 percent (n=8488). There were similar rates for intracranial hemorrhage (Activase, 0.9 percent; TNKase, 0.9 percent) and stroke (Activase, 1.7 percent; TNKase, 1.8 percent). In addition, non-intracranial major bleeding and the need for blood transfusions were lower in patients treated with TNKase compared to Activase. As with all thrombolytics, the most significant adverse events observed in clinical trials with TNKase included intracranial hemorrhage and stroke.

"Rapid treatment is critical to most effectively manage patients with heart attacks," said Dr. Granger. "The ability to treat patients rapidly depends on having simple treatments available which can be given easily in busy emergency departments."

About TNKase for Acute Myocardial Infarction

Genentech's leadership in cardiovascular medicine and in the development of thrombolytic therapy helped revolutionize heart attack treatment more than a decade ago. A bioengineered plasminogen activator, TNKase is similar to Activase, which is a recombinant DNA-derived version of naturally-occurring tissue plasminogen activator (t-PA). TNKase has unique features specifically designed to prolong its half life, enabling single bolus dosing. It also has been designed to increase specificity for fibrin, a key component of intracoronary clots and results in less disturbance of the body’s coagulation, or natural clotting, system.

TNKase (Tenecteplase) is currently under investigation in four ongoing clinical studies that began early this year, involving more than 9,000 patients, to evaluate various heart attack regimens in combination with other agents.

In addition to its clinical features, TNKase will be provided to the medical community as part of a kit which will include a needleless injection system, the first thrombolytic to be packaged with this device. This system is designed to comply with new OSHA (Occupational Safety and Health Administration) directives to protect health care workers.

Heart attack strikes more than 1.1 million people in the United States and causes nearly 500,000 deaths each year. Therapies and procedures that open the blocked artery causing the heart attack have been shown to significantly improve survival, but they must be administered within a few short hours of the onset of symptoms, which include chest pain or discomfort, difficulty breathing, "cold sweats," and nausea.

TNKase currently is under regulatory review by the European Regulatory Authority for the treatment of heart attack. Upon approval, TNKase will be marketed in Europe by Genentech's international marketing partner, Boehringer Ingelheim.

Genentech, Inc. is a leading biotechnology company that discovers, develops, manufactures and markets human pharmaceuticals for significant unmet medical needs. Fourteen of the approved products of biotechnology stem from Genentech science. Genentech markets eight products directly in the United States. The company has headquarters in South San Francisco, California, and is traded on the New York Stock Exchange under the symbol DNA.

For TNKase and Activase full prescribing information, please call 650-225-7848 or contact Genentech at www.gene.com.

Source: Genentech, Inc.

Posted: June 2000

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