Genentech adds TNKase to stroke treatment portfolio with FDA approval

USA—Genentech, a member of the Roche Group, has received approval from the U.S. Food and Drug Administration for TNKase® (tenecteplase) to treat acute ischemic stroke (AIS) in adults.

 This landmark decision not only marks a breakthrough in stroke management but also reinforces Genentech’s commitment to improving care for patients suffering from this life-altering condition.

This approval closely follows Boehringer Ingelheim’s introduction of an innovative medication designed to enhance the management of acute ischemic stroke (AIS) in the UAE.

Their treatment features tenecteplase at a 25 mg dosage, offering a faster and more efficient alternative to traditional therapies. As a result, both companies are advancing emergency care in stroke situations, highlighting the urgent need for rapid and effective intervention.

TNKase’s approval is particularly significant as it represents Genentech’s second major milestone in stroke treatment.

 The company has long been at the forefront of developing therapies for AIS, having previously brought Activase® (alteplase) to the market.

Unlike Activase, which requires an initial intravenous (IV) bolus followed by a 60-minute infusion, TNKase is given as a single five-second IV bolus.

This streamlined process not only simplifies administration but also reduces the time required to begin treatment, a factor that can be decisive when every second matters during an acute stroke.

In anticipation of this new application, Genentech has announced plans to introduce a 25 mg vial configuration in the coming months.

This adjustment is expected to support healthcare providers in effectively managing the dosing and administration of TNKase for stroke patients.

 According to Levi Garraway, M.D., Ph.D., Genentech’s chief medical officer and head of Global Product Development, TNKase’s rapid administration is a significant step forward.

 He stressed that this feature could be crucial in mitigating the extent of brain damage during an acute stroke, when timely treatment is paramount.

Stroke continues to be a major public health concern, ranking as the fifth leading cause of death and the foremost cause of long-term disability in the United States, where more than 795,000 people are affected each year.

Given that brain injury during AIS can progress rapidly and result in irreversible damage, the urgency for immediate medical care cannot be overstated.

The FDA’s decision was primarily based on the AcT (Alteplase compared to Tenecteplase) trial, a comprehensive, multi-center, non-inferiority study.

This investigator-initiated research, conducted by the University of Calgary and funded by the Canadian Institute of Health Research, involved 22 stroke centers across Canada and demonstrated that TNKase is comparable to Activase in terms of both safety and efficacy.

Moreover, TNKase already holds FDA approval for the treatment of acute ST-elevation myocardial infarction (STEMI) in adults, further underlining its value as an effective thrombolytic agent.

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