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| |  Canada Approves Single-Injection Clot Buster, TNKase (Tenecteplase), For Heart Attack MISSISSAUGA, ON -- October 22, 2001 -- Hoffmann-La Roche Limited (Roche) announced today that Health Canada has approved TNKase™ (tenecteplase) for the treatment of acute myocardial infarction (AMI). TNKase is the first single-injection thrombolytic agent approved by Health Canada for this indication. According to Dr. Paul Armstrong, Professor of Medicine (Cardiology) at the University of Alberta's Department of Medicine and lead Canadian investigator in the trial that resulted in Health Canada's approval of the drug, "TNKase represents an important advance in the way heart attack patients can be treated. What doctors and nurses in busy emergency departments will really appreciate about TNKase is its speed and convenience, since it can be given rapidly as a single shot in five seconds." The results of ASSENT 2 (ASsessment of the Safety and Efficacy of a New Thrombolytic agent) -- an international, 17,000-patient, pivotal study -- compared a weight-adjusted dose of TNKase with the approved 90-minute accelerated infusion of Activase® (alteplase, recombinant), another Roche product which is the most widely-used thrombolytic in Canada. TNKase was dosed in a weight-tiered fashion ranging from 30-50 mg based on actual or estimated weight of the patient. As reported in The Lancet in August, 1999, ASSENT 2 demonstrated the efficacy of TNKase was identical to Activase as indicated by the mortality rates in the two groups (TNKase 6.2 percent (n = 8461); Activase 6.2 percent (n = 8488). As with all thrombolytics, the most significant adverse events observed in clinical trials with TNKase included intracranial haemorrhage and stroke. While the rates of intracranial haemorrhage were the same (Activase, 0.9 percent; TNKase, 0.9 percent), significantly fewer non-cerebral bleeding complications (26.43 versus 28.95 percent, p = 0.0003) and less need for blood transfusion (4.25 versus 5.49 percent, p = 0.0002) were seen with TNKase. "Its strong safety and efficacy profile, combined with its five-second, single-bolus dosing makes TNKase the optimal therapy for patients experiencing a heart attack" says Dr. Pierre Théroux, Professor of Medicine (Cardiology) at the University of Montreal, Director of the Coronary Care Unit at the Montreal Heart Institute, and also a leading investigator in international research. "With TNKase we have reached a new frontier in the treatment of heart attacks that will change the way heart attacks are treated across the country." SOURCE: Hoffmann-La Roche Limited (Roche Canada) Related Link: Hoffmann-La Roche Limited.
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