FDA Approves Tenecteplase as First Stroke Drug in Nearly 30 Years

The US Food and Drug Administration has approved Tenecteplase as first FDA-approved stroke medication in nearly three decades. It offers a significant advantage over alteplase by enabling faster administration, potentially improving outcomes for stroke patients.

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 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.”

Stroke is the fifth leading cause of death, and the leading cause of long-term disability in the United States, affecting more than 795,000 people each year. During an AIS, brain damage occurs and progresses rapidly, meaning every moment without intervention leads to irreversible loss of nervous tissue, making immediate medical care crucial.

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.

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

About TNKase® (tenecteplase)

TNKase® (tenecteplase) is a tissue plasminogen activator, clot-dissolving, thrombolytic medicine. TNKase is administered as a single five-second intravenous bolus and starts a biochemical reaction that can break down fibrin, a component of blood clots. The most frequent adverse reactions associated with tenecteplase are bleeding and hypersensitivity. TNKase is now indicated for the treatment of acute ischemic stroke (AIS) in adults. The Dosage and Administration section of the label recommends to initiate treatment as soon as possible and within 3 hours after the onset of stroke symptoms. TNKase is also indicated to reduce the risk of death associated with acute ST-elevation myocardial infarction (STEMI). The Dosage and Administration section of the label recommends initiating treatment as soon as possible after the onset of STEMI symptoms. Alteplase and tenecteplase are marketed and supplied by Genentech in the United States and Canada under the brands Activase and TNKase; and by Boehringer Ingelheim in all other countries except the United States, Canada and Japan under the brands Actilyse® and Metalyse®.