Genentech gets TNKase approval

DNA received FDA marketing approval for its rapid onset TNKase tenecteplase tPA, a single-bolus thrombolytic agent to treat acute myocardial infarction. The approval came on the back of Phase III data in 17,000 patients, which compared TNKase with DNA's first generation version of tPA, Activase alteplase. The trial showed the same mortality rates with TNKase and Activase at 6.2 percent, similar intracranial hemorrhage at 0.9 percent, and stroke at 1.7 percent with Activase and 1.8 percent with TNKase. The advantage of TNKase, DNA said, is that its longer half-life means it can be given as a single bolus infusion instead of the 90-minute infusion required with Activase. ...