FDA approves TNKase for acute ischemic stroke in adults

Key takeaways:

• TNKase is the first stroke treatment approved by the FDA in almost 30 years, the manufacturer said.
• It is approved for administration as a single 5-second IV bolus.

The FDA has approved TNKase, a tissue plasminogen, clot-dissolving agent, to treat acute ischemic stroke in adults, according to the manufacturer.

Genentech said in a press release that TNKase (tenecteplase) has been approved as a one-time, 5-second IV bolus. It is the second FDA-approved treatment for acute ischemic stroke, the other being Activase (alteplase), also manufactured by Genentech, the release said. Tenecteplase is the first acute ischemic stroke treatment to be approved in nearly 30 years, according to the company.

"The approval of TNKase represents a meaningful advancement in stroke care, giving medical professionals, for the first time, a choice between two FDA-approved medicines for acute ischemic stroke,” Gregory A. Rippon, MD, MS, FAAN, vice president and chief medical partner for Neurology, Ophthalmology and Internal Medicine at Genentech, told Healio. “This milestone strengthens our commitment to improving patient outcomes and empowers providers to deliver timely, effective care when every second counts."

The approval of tenecteplase was based on results of a multicenter noninferiority clinical trial, AcT (Alteplase compared to Tenecteplase), conducted by the University of Calgary. The study compared IV tenecteplase to alteplase in almost 1,600 individuals with acute ischemic stroke recruited across 22 Canadian stroke centers, with results showing 0.25 mg/kg tenecteplase was considered a safe and efficacious alternative to alteplase.

Genentech said it plans to release a 25 mg vial configuration in the coming months to support the approval of tenecteplase.

Reference:

Menon BK, et al. Lancet Neurol. 2022;doi:10.1016/S0140-6736(22)01054-6.