Roche breaks 30-year gap with new stroke drug approval

SWITZERLAND – For the first time in nearly three decades, the FDA has approved a new stroke treatment, Roche’s TNKase (tenecteplase), offering a faster and simpler option for patients suffering from acute ischemic stroke.

The approval marks a significant milestone, as the only other FDA-approved stroke drug remains Activase (alteplase), also developed by Roche’s Genentech unit.

TNKase is a genetically modified version of alteplase that has higher specificity for fibrin and is more resistant to inactivation.

This allows it to stay in the body longer, meaning it can be given as a single five-second IV bolus, unlike alteplase, which requires an IV bolus followed by a 60-minute infusion.

Both drugs work by breaking up blood clots to restore blood flow in the critical early hours of a stroke, preventing severe brain damage.

However, they must be administered within a limited time window and only after ruling out a hemorrhagic stroke, which is caused by bleeding rather than a clot.

The FDA label for TNKase recommends giving the drug within three hours of symptom onset, slightly shorter than the four-and-a-half-hour window approved in Europe, where it is sold as Metalyse by Boehringer Ingelheim.

A project revived after setbacks

Roche nearly abandoned the stroke approval effort in 2023 after an underwhelming readout from the TIMELESS trial.

However, the company continued analyzing data and ultimately based its FDA submission on the large AcT study, which showed TNKase was as effective and safe as Activase.

Levi Garraway, Genentech’s chief medical officer, emphasized the drug’s potential impact: “TNKase provides a faster and simpler administration, which can be critical for anyone dealing with an acute stroke.”

A game-changer for stroke patients

Stroke is the fifth leading cause of death and the leading cause of long-term disability in the US, affecting over 795,000 people each year.

Faster treatment options like TNKase could make a crucial difference, as every minute counts in preventing long-term damage.

TNKase has already been FDA-approved for acute myocardial infarction (heart attack) since 2000.

While Roche does not separate Activase and TNKase sales, the two drugs together generated over US $1.35 billion in 2023.