Roche’s clot-dissolving agent TNKase (tenecteplase) racked up its second FDA approval on Monday, earning a nod to treat acute ischaemic stroke (AIS) in adults.
The drug was designed to be delivered more quickly than the current standard-of-care stroke treatment, Roche’s Activase (alteplase). TNKase is given as a single five-second intravenous (IV) bolus, while Activase requires a 60-minute infusion.
«TNKase provides a faster and simpler administration, which can be critical for anyone who is dealing with an acute stroke,» commented Levi Garraway, the chief medical officer and head of global product development at Roche’s Genentech unit.
Monday’s green light was based on the results of the investigator-initiated AcT trial, which compared TNKase with Activase in AIS patients admitted to 22 stroke centres who presented with a disabling neurological deficit. The study, conducted by the University of Calgary and funded by the Canadian Institute of Health Research, found that TNKase’s efficacy and safety is comparable to that of Activase.
TNKase was first approved to treat acute ST-elevation myocardial infarction (STEMI) in adults more than two decades ago.
Together, Activase and TNKase brought in a combined CHF1.2 billion ($1.3 billion) in sales for Roche last year, which the pharma said represents a 5% boost over 2023 revenues mainly due to increasing demand in AIS.