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Conexiant chevron_right Neurology chevron_right FDA Approves First New Stroke Thrombolytic in 30 Years
FDA & Government News

FDA Approves First New Stroke Thrombolytic in 30 Years

The FDA has approved tenecteplase for acute ischemic stroke, offering a faster and simpler administration compared to alteplase based on findings from the AcT trial.

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The FDA has recently approved tenecteplase (TNKase) as a thrombolytic agent for the treatment of acute ischemic stroke (AIS) in adults, marking the first AIS thrombolytic approval in nearly 30 years. TNKase offers a simplified administration compared to alteplase (Activase) and has been shown to be comparable to Activase in terms of safety and efficacy. The approval is based on the AcT trial, demonstrating TNKase's efficacy in treating AIS patients. Stroke, the fifth leading cause of death in the United States, can lead to irreversible nervous tissue loss, making immediate medical care crucial. Genentech, who developed TNKase, plans to introduce a new 25 mg vial configuration to support tenecteplase use in stroke management.

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