Genentech has secured a second marketed stroke therapy after the US Food and Drug Administration (FDA) approved a label expansion for clot-dissolving agent TNKase (tenecteplase) – the first stroke medicine approved by the agency in almost 30 years.
TNKase will be available for the treatment of acute ischemic stroke in adults, joining the Roche subsidiary’s Activase (alteplase) on the market – also approved for the same indication.
Before TNKase, Activase was the only pharmacological treatment approved by the FDA for acute ischemic stroke. Whilst Genentech has enjoyed market domination since 1996 – the year in which Activase was approved – the company pursued TNKase’s approval for the disease to offer a faster and simpler administration method.
Genentech’s new stroke drug is delivered as a single five-second intravenous (IV) bolus, whereas Activase is administered as an IV bolus followed by a one-hour infusion. The differences in administration come down to TNKase’s longer half-life and higher fibrin specificity. Genentech said it will also introduce a new 25mg vial configuration in the coming months to support the approval of TNKase in its latest indication.
The expanded approval of TNKase was based on a non-inferiority study (NCT03889249) across 22 stroke centres in Canada that demonstrated it performs comparably to Activase in terms of safety and efficacy in acute ischemia patients.
Stroke is the fifth leading cause of death in the US, according to the US Centers for Disease Control and Prevention (CDC). More than 795,000 people in the US have a stroke each year, with 87% of those being ischemic stroke.
TNKase is one of Genentech’s cardiovascular staples, having been approved nearly 25 years ago for the treatment of heart attacks and acute myocardial infarctions. The drug works by breaking down fibrin, a component of blood clots. It is a modified version of a tissue plasminogen activator and helps blood flow freely again without causing systemic bleeding.
Combined global sales of TNKase and Activase generated SFr1.2bn ($1.35bn) last year, as per Roche’s product sales report. GlobalData’s Pharma Intelligence Center expects peak sales to come this year, with future sales potentially impacted by increased competition and shortages. TNKase, under a different brand name in Europe, already experienced a shortage in 2022.
GlobalData is the parent company of Pharmaceutical Technology.
Boehringer Ingelheim markets Activase and TNKase under the brand names Actilyse and Metalyse, respectively, outside the US, Canada and Japan.
