FDA Approves New, Single-Injection Clot Buster TNKase `Tenecteplase' for Treatment of Heart Attack; First Thrombolytic That Can Be Administered Over Five Seconds In One Dose.Business Editors & Health/Medical Writers NOTE TO MEDIA: Photo is available in a Smart News Release(TM) on Business Wire's Home Page at www.businesswire.com SOUTH SAN FRANCISCO South San Francisco, city (1990 pop. 54,312), San Mateo co., W Calif.; inc. 1908. South San Francisco has several industrial parks; its manufactures include medical supplies and equipment, foods, paint, paper products, consumer goods, and clothing. , Calif.--(BW HealthWire)--June 2, 2000 Genentech, Inc. (NYSE NYSE See: New York Stock Exchange :DNA DNA: see nucleic acid. DNA or deoxyribonucleic acid One of two types of nucleic acid (the other is RNA); a complex organic compound found in all living cells and many viruses. It is the chemical substance of genes. ) announced today that TNKase(TM) (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 acute myocardial infarction (  ·kyōōtˑ mī·ō·karˑ·dē· (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 Arthur D. Levinson (born March 31, 1950 in Seattle, Washington, United States) is President and Chief Executive Officer of Genentech. He has held these positions since July 1995, and was named chairman of the board of directors in 1999. , 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(R) (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 FACC Fellow, American College of Cardiology , 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(TM) (Tenecteplase), 6.2 percent (n=8461); Activase(R) (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 tissue plasminogen activator n. Abbr. TPA 1. An enzyme that catalyzes the conversion of plasminogen to plasmin, used to dissolve blood clots rapidly and selectively, especially in the treatment of heart attacks. 2. (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 coagulation (kōăg'y  lā`shən), the collecting into a mass of minute particles of a solid dispersed throughout a liquid (a sol), usually followed by the precipitation or , or natural clotting, system. TNKase(TM) (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 OSHA n. Occupational Safety and Health Administration, a branch of the US Department of Labor responsible for establishing and enforcing safety and health standards in the workplace. (Occupational Safety and Health Administration Occupational Safety and Health Administration (OSHA), U.S. agency established (1970) in the Dept. of Labor (see Labor, United States Department of) to develop and enforce regulations for the safety and health of workers in businesses that are engaged in interstate ) 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 South San Francisco is a city in San Mateo County, California, United States, located on the San Francisco Peninsula in the San Francisco Bay Area. The population was 60,552 at the 2000 census. , and is traded on the New York Stock Exchange New York Stock Exchange (NYSE) World's largest marketplace for securities. The exchange began as an informal meeting of 24 men in 1792 on what is now Wall Street in New York City. under the symbol DNA. For TNKase and Activase full prescribing information, please call 650-225-7848 or contact Genentech at www.gene.com. Note: A Photo is available at URL URL in full Uniform Resource Locator Address of a resource on the Internet. The resource can be any type of file stored on a server, such as a Web page, a text file, a graphics file, or an application program. : http://www.businesswire.com/cgi-bin/photo.cgi?pw.060200/bw2 |
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