Roche Gets FDA Approval for Acute Ischemic Stroke Drug for Adults [Yahoo! Finance]
ROCHE HOLDING LTD S/ADR (RHHBY)
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Source: Yahoo! Finance
As a result of the approval, Genentech has the only two FDA-approved medicines to treat AIS in its portfolio, namely TNKase and Activase (alteplase). TNKase is a tissue plasminogen activator, clot-dissolving, thrombolytic medicine. It is delivered as a single five-second intravenous (IV) bolus, a faster and simpler administration compared to the standard-of-care Activase, which is administered as an IV bolus followed by a 60-minute infusion. The FDA approval is based on a large multi-center non-inferiority study that showed that TNKase is comparable to Activase in terms of safety and efficacy in AIS patients. Stroke is the fifth leading cause of death. It is also the leading cause of long-term disability in the United States and affects more than 795,000 people annually. TNKase is also FDA-approved for the treatment of acute ST-elevation myocardial infarction in adults. Roche's shares have risen 30.6% year to date compared with the large cap pharmaceutical industry's rise o
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