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.
ASSENT 2 yielded the following mortality rates: TNKase(TM) (Tenecteplase), 6.
The results of the ASSENT 2 trial (ASsessment of the Safety and Efficacy of a New Thrombolytic agent) will be submitted by Genentech as part of a biological licensing application (BLA) to the U.
With more than 1,000 sites in 29 countries, ASSENT 2 was designed as a randomized, double-blind, parallel group trial of a weight-adjusted, 30-50 mg single bolus of tenecteplase versus the 90-minute accelerated infusion of Activase in AMI patients.
The ASSENT 2 results demonstrate that tenecteplase may have great promise as a potential new weight-adjusted thrombolytic agent for treatment of heart attack patients, with the added convenience of single bolus administration," said Arthur D.
The promising outcomes of previous studies led to Phase III testing in ASSENT 2.