Over nearly the last three decades, Genentech has had the lone medicine on the market for the acute treatment of stroke. Monday, the Roche subsidiary added a second stroke treatment to its repertoire, gaining an FDA endorsement for TNKase (tenecteplase).

The tissue plasminogen activator, clot-dissolving, thrombolytic medicine has been approved for adults with acute ischemic stroke (AIS). TNKase can be shot into the arm in five seconds, making it a faster treatment option compared to its forerunner, Activase (alteplase), which was approved for heart attack in 1987 and for stroke in 1996. Activase is administered as an IV bolus followed by a 60-minute infusion.

TNKase is not a new treatment. It was approved in 2000 to reduce the risk of death from heart attack—acute ST elevation myocardial infarction—which is what happens when a coronary artery is completely blocked.

"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., Genentech’s chief medical officer and head of global product development, said in a statement. “TNKase provides a faster and simpler administration, which can be critical for anyone who is dealing with an acute stroke.”

Roche also will be introducing a new 25-mg vial configuration in the coming months to support the latest approval of TNKase, the company said.

The medications can limit the brain damage that takes place following a stroke. Because the loss of nervous tissue can occur quickly, timing is an important factor to minimize the irreversible damage.

TNKase triggers a biochemical reaction that can break down fibrin, a component of blood clots, Genentech explained. The label recommends initiating treatment as soon as possible and within three hours after the onset of stroke symptoms.

Stroke is the fifth-leading cause of death and the leading cause of long-term disability in the U.S., affecting more than 795,000 people each year, according to Genentech.

The approval of TNKase to treat AIS was based on a noninferiority study that demonstrated it performs comparably to Activase in measurements of safety and efficacy. The study was funded by the Canadian Institute of Health Research and included patients at 22 stroke centers in Canada.

Roche reported combined sales of 1,202 billion Swiss francs ($1.34 billion) for Activase and TNKase in 2024, an increase of 5% year over year. Boehringer Ingelheim markets the drugs under the brand names Actilyse and Metalyse, respectively, in countries other than the U.S., Canada and Japan.