FDA Approves TNKase for Acute Ischemic Stroke
.jpg?width=1200)
THURSDAY, March 6, 2025 -- 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.
Disclaimer: Statistical data in medical articles provide general trends and do not pertain to individuals. Individual factors can vary greatly. Always seek personalized medical advice for individual healthcare decisions.
© 2025 HealthDay. All rights reserved.
Read this next
Household Items Tied to Sharp Increase in Self-Harm Cases in Teens
WEDNESDAY, Sept. 10, 2025 — Cases of self-harm involving 6- to 12-year-olds have risen sharply, and researchers warn that common household products are often...
Ultrasound Helmet Provides Surgery-Free Brain Stimulation
WEDNESDAY, Sept. 10, 2025 — Deep brain stimulation has shown promise in treating conditions ranging from epilepsy and Parkinson’s disease to cluster headaches...
Wireless Ultrasound: A Potential Revolution In Assessing On-Field Sports Injuries?
WEDNESDAY, Sept. 10, 2025 — The collegiate sports season is upon us, and with it the inevitable bruises, sprains and strains that come from tough competition. Portable...
More news resources
- FDA Medwatch Drug Alerts
- Daily MedNews
- News for Health Professionals
- New Drug Approvals
- New Drug Applications
- Drug Shortages
- Clinical Trial Results
- Generic Drug Approvals
Subscribe to our newsletter
Whatever your topic of interest, subscribe to our newsletters to get the best of Drugs.com in your inbox.