Genentech TNKase
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
Tenecteplase approved June 2 for reduction of mortality associated with acute myocardial infarction. TNKase is the first thrombolytic that "can be administered over five seconds in a single dose," the firm says. Genentech's older t-PA agent, Activase (alteplase), is dosed as either a three-hour or 90-minute accelerated infusion. TNKase will debut at the same direct-to-wholesaler price as Activase: $2,200 per dose. FDA's approval letter directs the firm to begin enrollment by September 30 for a registry study of African-American, Hispanic, and low body weight patients treated with TNKas
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