0
0
March 7, 2025 – The U.S. Food and Drug Administration (FDA) has granted approval for TNKase (tenecteplase), a thrombolytic agent, for the treatment of acute ischemic stroke in adults. This milestone offers a faster-acting alternative to the standard treatment, potentially improving patient outcomes in critical situations.
TNKase is administered as a single five-second intravenous bolus, a significant improvement over the current standard of care, Activase (alteplase), which requires an initial intravenous bolus followed by a 60-minute infusion. Genentech, the manufacturer of TNKase, has also announced the upcoming availability of a new 25-mg vial configuration in the coming months to support its use in clinical settings.
The FDA’s approval is based on a comparative study between TNKase and Activase in patients experiencing acute ischemic stroke with disabling neurological deficits. The results demonstrated that TNKase was comparable to Activase in terms of both efficacy and safety, reinforcing its viability as a treatment option.
Acute ischemic stroke remains a major public health concern, affecting more than 795,000 people annually in the United States. It is the leading cause of long-term disability and ranks as the fifth-leading cause of death. Given the rapid progression of brain damage during a stroke, immediate and effective treatment is crucial to improving patient outcomes.
Dr. Levi Garraway, M.D., Ph.D., chief medical officer and head of global product development at Genentech, emphasized the significance of this approval. “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.”
Disclaimer:
This article is for informational purposes only and does not constitute medical advice. Patients and healthcare providers should consult official prescribing information and medical professionals before making any treatment decisions.
