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| |  Retavase Heart Attack Drug Receives FDA Clearance GAITHERSBURG, Md.-- Oct. 30, 1996 -- Boehringer Mannheim Corporation, Therapeutics Division announced it has received clearance from the U.S. Food and Drug Administration (FDA) to market Retavase(TM) (reteplase), a new thrombolytic agent to help treat the 1.5 million American patients suffering from heart attack each year. An international study of more than 6,000 patients treated with either Retavase or streptokinase proved Retavase to be safe and effective in reducing mortality and lowering the incidence of CHF and other cardiovascular conditions(1). Additionally, clinical data show that Retavase was associated with a reduced need to perform emergency angioplasty compared to Alteplase(2). However, like all thrombolytics, Retavase does increase the risk of bleeding. "Retavase will provide physicians with a new drug that is simpler to administer and what may be the best option yet to dissolve clots and restore blood flow," said Richard Smalling, MD, co-director of cardiology, University of Texas Medical School, director of clinical medicine at Hermann Hospital in Houston, and an investigator in Retavase clinical trials. "In clinical trials, Retavase restored blood flow in significantly more patients after 90 minutes than Alteplase(2)(3)," summarized Dr. Smalling. In another patient group measuring blood flow at 60 minutes, Retavase also restored blood flow in significantly more patients than Alteplase(2). Thrombolytic agents are used to treat patients who suffer from heart attack, or what is medically known as acute myocardial infarction (AMI). Widespread research has shown that one of the most effective treatments for a heart attack as a result of blockage caused by a blood clot is to quickly administer a thrombolytic agent to restore blood flow to the affected artery. Retavase is the only thrombolytic that can be given in a simple two-shot form rather than a continuous intravenous infusion. "Strong evidence indicates that if you can open an artery early in a heart attack, you can save more lives," commented Dr. Smalling. "This makes Retavase very important for patients since data demonstrate Retavase opens arteries in more patients when compared with U.S. market-leader Alteplase(2)(4)." "Retavase represents a major advance in improving AMI management," said Daniel Odenheimer, Ph.D., director of clinical research, Boehringer Mannheim Corporation, Therapeutics Division. "Retavase will give physicians a new resource with demonstrated clinical benefits to improve the outlook for millions of people suffering from heart attack each year." Boehringer Mannheim Therapeutics expects to begin selling Retavase to physicians in early 1997. Retavase is a biotechnology product of Boehringer Mannheim Corporation GmbH research. The drug was developed and manufactured at Boehringer Mannheim, Penzberg, Germany, one of the largest, state-of-the-art biotechnology facilities in Europe. Boehringer Mannheim Corporation, Therapeutics Division (BMCT), a division of Indianapolis-based Boehringer Mannheim Corp., was established in Maryland in 1984 to focus on drug development. Launching commercial operations in 1991, BMCT today employs more than 400 people and is headquartered in Gaithersburg, Maryland. Privately-held Boehringer Mannheim Group, founded in 1859, has divisions in biochemicals, diagnostics and therapeutics, which contributed to the company's $3.27 billion in worldwide sales in 1995. (1) Lancet 1995; 346:329-336. (2) (Alteplase) Activase(R) is a registered trademark of Genentech, Inc. (3) RAPID II (Reteplase and Alteplase Patency Investigation During Myocardial Infarction), Circulation 1996; 94:891-898. (4) RAPID I (Reteplase Angiographic Phase II International Dose Finding Studies), Circulation 1995;91:2725-2732.
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