SOUTH SAN FRANCISCO, Calif. — Genentech announced FDA approval of TNKase — tenecteplase — for treating acute ischemic stroke (AIS) in adults. This marks Genentech’s second FDA-approved AIS treatment alongside Activase.
TNKase is a faster, simpler stroke treatment, given as a single five-second IV bolus, unlike Activase’s 60-minute infusion. Genentech will soon launch a new 25 mg vial to support its AIS approval, the company stated in a press release.
“Today’s approval is a significant step forward and underscores our commitment to advancing stroke treatment options for patients,” Genentech’s Chief Medical Officer and head of Global Product Development Levi Garraway, M.D., Ph.D., said. “TNKase provides a faster and simpler administration, which can be critical for anyone who is dealing with an acute stroke.”
The approval is based on the AcT trial, a large multi-center study showing TNKase is as safe and effective as Activase for AIS patients with disabling neurological deficits. Led by the University of Calgary and funded by the Canadian Institute of Health Research, the study enrolled patients across 22 stroke centers in Canada.
