FDA approves TNKase (tenecteplase) in acute ischemic stroke in adults – Genentech/ Roche

Genentech, a member of the Roche Group  announced that the  FDA  has approved TNKase (tenecteplase), a thrombolytic or clot-dissolving agent, for the treatment of acute ischemic stroke (AIS) in adults. This approval of TNKase marks Genentech’s second approval for stroke, reinforcing the company’s long-standing dedication to advancing stroke care as the developer of the only two FDA-approved medicines for AIS, TNKase and Activase (alteplase). TNKase (tenecteplase) is the first stroke medicine approved by the FDA in nearly 30 years.

TNKase is delivered as a single five-second intravenous (IV) bolus, a faster and simpler administration compared to the standard-of-care, Activase, which is administered as an IV bolus followed by a 60-minute infusion. Genentech will also be introducing a new 25 mg vial configuration in the coming months to support the approval of TNKase for AIS.

The approval is based on a large multi-center non-inferiority study demonstrating that TNKase is comparable to Activase in AIS patients in terms of safety and efficacy. The AcT (Alteplase compared to Tenecteplase) trial compared TNKase to Activase in treating patients with acute ischemic stroke who presented with a disabling neurological deficit. This investigator-initiated study was conducted by the University of Calgary, was funded by the Canadian Institute of Health Research, and enrolled patients across 22 stroke centers in Canada.

“The approval is a significant step forward and underscores our commitment to advancing stroke treatment options for patients,” said Dr. Levi Garraway, Genentech’s chief medical officer and head of Global Product Development. “TNKase provides a faster and simpler administration, which can be critical for anyone who is dealing with an acute stroke.”