FDA Approves Genentech's TNKase for Acute Ischaemic Stroke

Roche's Genentech division has achieved a notable milestone with the approval of TNKase (tenecteplase) by the US Food and Drug Administration (FDA) for treating acute ischaemic stroke (AIS) in adults. This marks the first time in almost 30 years that the FDA has approved a new medication specifically for stroke. Stroke ranks as the fifth leading cause of death and the foremost reason for long-term disability in the United States, impacting over 795,000 individuals annually. Acute ischaemic strokes occur when an obstruction or reduction in blood flow to a part of the brain deprives brain tissue of essential oxygen and nutrients.

TNKase is categorized as a tissue plasminogen activator, a type of clot-dissolving thrombolytic medication. It initiates a biochemical reaction that breaks down fibrin, a key component of blood clots. Until TNKase's approval, Roche/Genentech's Activase (alteplase) was the sole FDA-sanctioned medication for AIS, which required administration via an intravenous (IV) bolus followed by a 60-minute infusion.

In contrast, TNKase offers a more streamlined treatment option by being administered as a single five-second IV bolus. This simplified and expedited method of administration represents a significant improvement over the existing treatment. TNKase is not new to the market, as it is already approved in the United States for treating acute ST-elevation myocardial infarction in adults.

The FDA's recent approval was underpinned by a comprehensive multi-centre non-inferiority study that confirmed TNKase's safety and efficacy were on par with Activase in patients with AIS. Levi Garraway, Genentech's chief medical officer and head of global product development, emphasized the importance of this approval. He stated that it represents a significant advancement in stroke treatment options, highlighting the critical nature of faster and simpler administration for individuals experiencing an acute stroke.

This regulatory milestone occurs just weeks after the FDA's approval of a tablet formulation of Roche's Evrysdi (risdiplam), a treatment for spinal muscular atrophy. Initially approved by the US regulator in 2020 for patients aged two months and older, Evrysdi received expanded approval in 2022 for infants under two months. The new tablet form can be swallowed whole or dispersed in water and stored at room temperature, offering more flexibility and independence compared to the original oral solution.

The introduction of TNKase provides a pivotal step forward in stroke management, offering healthcare professionals and patients a more efficient option in the treatment of acute ischaemic stroke. As strokes continue to present significant health challenges, the availability of TNKase may greatly enhance the speed and simplicity of treatment, potentially improving outcomes for thousands of patients in need.