FDA Approves TNKase for Acute Ischemic Stroke

THURSDAY, March 6, 2025 (HealthDay News) — The U.S. Food and Drug Administration has approved TNKase (tenecteplase), a thrombolytic or clot-dissolving agent, for the treatment of acute ischemic stroke in adults.

TNKase is delivered as a single five-second intravenous bolus. This is considerably faster than the standard of care, Activase (alteplase), which is administered as an intravenous bolus followed by a 60-minute infusion. Genentech, the manufacturer of TNKase, says a new 25-mg vial configuration will be available in the coming months.

The approval is based on a study comparing TNKase to Activase in patients with acute ischemic stroke who presented with a disabling neurological deficit. Results show that TNKase was comparable to Activase in terms of efficacy and safety.

Stroke affects more than 795,000 people each year in the United States. It is the leading cause of long-term disability and the fifth leading cause of death. Since brain damage occurs and progresses rapidly during an acute ischemic stroke, immediate, fast-acting medical care is vital.

“Today”s approval is a significant step forward and underscores our commitment to advancing stroke treatment options for patients,” Levi Garraway, M.D., Ph.D., the chief medical officer and head of global product development at Genentech, said in a statement. “TNKase provides a faster and simpler administration, which can be critical for anyone who is dealing with an acute stroke.”

Approval of TNKase was granted to Genentech.

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