The U.S. Food and Drug Administration (FDA) has approved Genentech’s TNKase (tenecteplase), a thrombolytic or clot-dissolving agent, for the treatment of acute ischemic stroke (AIS) in adults.

This approval marks Genentech’s second approval for stroke, reinforcing its dedication to advancing stroke care as the developer of the only two FDA-approved medicines for AIS: TNKase and Activase (alteplase). Genentech is a member of the Roche Group.

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.

“Today’s approval is a significant step forward and underscores our commitment to advancing stroke treatment options for patients,” said Levi Garraway, M.D., Ph.D., 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.”

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.

TNKase is also FDA-approved for the treatment of acute ST-elevation myocardial infarction (STEMI) in adults.