FDA approves first new clot-dissolving drug for ischemic stroke in decades
Genentech, part of the Roche Group, has received U.S. Food and Drug Administration (FDA) approval for tenecteplase, the company’s new intravenous treatment for acute ischemic stroke (AIS) in adult patients. Genentech will be marketing and selling tenecteplase under the brand name TNKase.
Tenecteplase is only the second clot-busting medication for stroke to gain approval from the FDA—and the first in decades. The only other one, alteplase, is also sold by Genentech under the brand name Activase.
Tenecteplase is a tissue plasminogen activator given to patients through a single five-second intravenous bolus. This is much faster than alteplase, which was administered by giving patients an IV bolus that is then followed by a 60-minute infusion.
“Today’s approval is a significant step forward and underscores our commitment to advancing stroke treatment options for patients,” Levi Garraway, MD, PhD, Genentech’s chief medical officer and head of global product development, said in a statement. “TNKase provides a faster and simpler administration, which can be critical for anyone who is dealing with an acute stroke.”
Bleeding events and hypersensitivity are the most common adverse reactions associated with tenecteplase.
Genentech recommends that treatment be initiated within three hours of the presentation of a patient’s stroke symptoms. The company also noted that this drug should not be given to patients with active internal bleeding, a recent history of brain or spinal surgery or severe uncontrolled high blood pressure.
Tenecteplase has also been approved by the FDA for the treatment of acute ST-elevation myocardial infarction (STEMI) in adult patients, and should be given to patients as soon as possible following the onset of STEMI symptoms.
While tenecteplase and alteplase are marketed and distributed by Genentech in the United States and Canada, those rights are owned by Boehringer Ingelheim elsewhere in the world. In those countries, tenecteplase and alteplase are sold under the brand names Actilyse and Metalyse, respectively.
Michael has more than 18 years of experience as a professional writer and editor. He has written at length about cardiology, radiology, artificial intelligence and other key healthcare topics.