Genentech, a member of the Roche Group, has announced the US Food and Drug Administration (FDA) approval of the thrombolytic agent TNKase (tenecteplase) for the treatment of acute ischaemic stroke in adult patients. According to a company press release, this marks the first US FDA approval of a new stroke medicine for nearly 30 years.
The approval is also Genentech’s second for stroke, which the company claims reinforces its “long-standing dedication” to advancing stroke care as the developer of “the only two US FDA-approved medicines for acute ischaemic stroke”—TNKase and Activase (alteplase).
TNKase is delivered as a single five-second intravenous (IV) bolus, representing a faster and simpler administration process compared to standard-of-care Activase, which is administered as an IV bolus followed by a 60-minute infusion. Genentech says it will also be introducing a new 25mg vial configuration in the coming months to support this approval of TNKase for acute ischaemic stroke.
“Today’s approval is a significant step forward and underscores our commitment to advancing stroke treatment options for patients,” commented Levi Garraway, Genentech’s chief medical officer and head of global product development. “TNKase provides a faster and simpler administration, which can be critical for anyone who is dealing with an acute stroke.”
According to Genentech, this approval is based on a large multicentre non-inferiority study demonstrating that TNKase is comparable to Activase in acute ischaemic stroke patients in terms of safety and efficacy. The AcT trial—an investigator-initiated study that enrolled patients across 22 stroke centres in Canada—compared the two drugs in treating patients with acute ischaemic stroke that presented with a disabling neurological deficit.
TNKase is also US FDA-approved for the treatment of acute ST-elevation myocardial infarction (STEMI) in adult patients.
