Approval marks the first new stroke treatment in 30 years

The FDA has approved tenecteplase (TNKase) for the treatment of acute ischemic stroke (AIS) in adults, marking the first new stroke-specific thrombolytic approval in nearly three decades. Administered as a single five-second intravenous bolus, tenecteplase allows for faster administration compared to the current standard of care alteplase, which is administered as a bolus-plus-infusion regimen.

Stroke remains the fifth leading cause of death and the leading cause of long-term disability in the US, affecting over 795,000 people annually.¹ Timely thrombolysis is essential, as delays can result in significant neuronal loss.²

The FDA’s decision was informed by findings from the AcT (Alteplase compared to Tenecteplase) trial, a large, multi-centre, non-inferiority study comparing tenecteplase and alteplase in stroke patients [NCT03889249].³ Conducted by the University of Calgary and funded by the Canadian Institute of Health Research, the investigator-initiated study enrolled patients across 22 stroke centres in Canada. The results demonstrated that tenecteplase was non-inferior to alteplase in terms of both efficacy and safety, reinforcing its potential as a practical alternative for AIS management. The primary adverse reactions associated with tenecteplase include bleeding and hypersensitivity.

References:

1. Tsao CW, Aday AW, Almarzooq ZI, et al. Heart disease and stroke statistics—2023 update: a report from the American Heart Association. Circulation. 2023;147:e93–e621.
2. Diana L Alsbrook DL, Di Napoli M, Bhatia K et al.  Neuroinflammation in Acute Ischemic and Hemorrhagic Stroke. Curr Neurol Neurosci Rep. 2023;23:407–31. doi: 10.1007/s11910-023-01282-2.
3. Menon  BK, Buck BH, Singh N, et al. Intravenous tenecteplase compared with alteplase for acute ischaemic stroke in Canada (AcT): a pragmatic, multicentre, open-label, registry-linked, randomised, controlled, non-inferiority trial. Lancet. 2022;400:161–9.

Disclosures: This article was created by the touchNEUROLOGY team utilizing AI as an editorial tool (ChatGPT (GPT-4o) [Large language model]. https://chat.openai.com/chat.) The content was developed and edited by human editors. No funding was received in the publication of this article.

Register now to receive the touchNEUROLOGY newsletter!

Don’t miss out on hearing about our latest peer reviewed articles, expert opinions, conference news, podcasts and more.

Register Register