Roche Expands Stroke Treatment Options with FDA Approval for TNKase

Roche's subsidiary Genentech has received FDA approval for TNKase (tenecteplase) to treat acute ischemic stroke (AIS) in adults, marking a significant advancement in stroke care. This label expansion adds a second stroke treatment to Genentech's portfolio, complementing its long-standing medication Activase.

TNKase: A Faster Option for Stroke Treatment

TNKase, already approved for heart attack treatment since 2000, offers a quicker administration method compared to its predecessor. The tissue plasminogen activator can be administered as a single shot into the arm in just five seconds, potentially saving crucial time in stroke treatment.

Dr. Levi Garraway, Genentech's chief medical officer and head of global product development, emphasized the importance of this approval, stating, "Today's approval is a significant step forward and underscores our commitment to advancing stroke treatment options for patients. TNKase provides a faster and simpler administration, which can be critical for anyone who is dealing with an acute stroke."

Clinical Efficacy and Market Impact

The FDA's decision was based on a noninferiority study funded by the Canadian Institute of Health Research, which demonstrated that TNKase performs comparably to Activase in terms of safety and efficacy. The study involved patients from 22 stroke centers in Canada.

Roche reported combined sales of 1,202 billion Swiss francs ($1.34 billion) for Activase and TNKase in 2024, representing a 5% year-over-year increase. To support the new approval, Roche plans to introduce a new 25-mg vial configuration of TNKase in the coming months.

Addressing a Critical Health Concern

Stroke remains a significant health issue in the United States, ranking as the fifth-leading cause of death and the primary cause of long-term disability. It affects more than 795,000 people annually, according to Genentech.

The approval of TNKase for AIS treatment provides healthcare professionals with an additional tool to combat this prevalent condition. The medication works by triggering a biochemical reaction that breaks down fibrin, a key component of blood clots. For optimal results, treatment should be initiated as soon as possible and within three hours after the onset of stroke symptoms.