Roche (RHHBY.US) innovative therapy receives FDA approval for treating adult acute ischemic stroke.
04/03/2025
GMT Eight
Roche's subsidiary Genentech announced that the US FDA has approved the thrombolytic agent TNKase (tenecteplase) for the treatment of adult acute ischemic stroke (AIS). The press release notes that TNKase is the first stroke drug approved by the FDA in nearly 30 years. TNKase is administered through a five-second intravenous bolus injection, which is faster and more convenient than the standard treatment Activase (initial intravenous bolus followed by 60-minute infusion), also developed by Roche.
TNKase is a tissue plasminogen activator that has the ability to dissolve blood clots. Administered through a five-second intravenous bolus injection, TNKase initiates a biochemical reaction that breaks down the components of the blood clot, fibrin. The most common adverse reactions of TNKase are bleeding and allergic reactions. Research results show that in patients with acute ischemic stroke, TNKase is comparable to Activase in terms of safety and efficacy.