Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that the U.S. Food and Drug Administration (FDA) has approved TNKase® (tenecteplase), a thrombolytic or clot-dissolving agent, for the treatment of acute ischemic stroke (AIS) in adults. This approval of TNKase marks Genentech’s second approval for stroke, reinforcing the company’s long-standing dedication to advancing stroke care as the developer of the only two FDA-approved medicines for AIS, TNKase and Activase® (alteplase).
TNKase is delivered as a single five-second intravenous (IV) bolus, a faster and simpler administration compared to the standard-of-care, Activase, which is administered as an IV bolus followed by a 60-minute infusion. Genentech will also be introducing a new 25 mg vial configuration in the coming months to support the approval of TNKase for AIS.
“Today’s approval is a significant step forward and underscores our commitment to advancing stroke treatment options for patients,” said Levi Garraway, M.D., Ph.D., Genentech’s chief medical officer and head of Global Product Development. “TNKase provides a faster and simpler administration, which can be critical for anyone who is dealing with an acute stroke.”
Stroke is the fifth leading cause of death, and the leading cause of long-term disability in the United States, affecting more than 795,000 people each year. During an AIS, brain damage occurs and progresses rapidly, meaning every moment without intervention leads to irreversible loss of nervous tissue, making immediate medical care crucial.
The approval is based on a large multi-center non-inferiority study demonstrating that TNKase is comparable to Activase in AIS patients in terms of safety and efficacy. The AcT (Alteplase compared to Tenecteplase) trial compared TNKase to Activase in treating patients with acute ischemic stroke that presented with a disabling neurological deficit. This investigator-initiated study was conducted by the University of Calgary, was funded by the Canadian Institute of Health Research, and enrolled patients across 22 stroke centers in Canada.
TNKase is also FDA approved for the treatment of acute ST-elevation myocardial infarction (STEMI) in adults.
About TNKase® (tenecteplase)
TNKase® (tenecteplase) is a tissue plasminogen activator, clot-dissolving, thrombolytic medicine. TNKase is administered as a single five-second intravenous bolus and starts a biochemical reaction that can break down fibrin, a component of blood clots. The most frequent adverse reactions associated with tenecteplase are bleeding and hypersensitivity. TNKase is now indicated for the treatment of acute ischemic stroke (AIS) in adults. The Dosage and Administration section of the label recommends to initiate treatment as soon as possible and within 3 hours after the onset of stroke symptoms.
TNKase is also indicated to reduce the risk of death associated with acute ST-elevation myocardial infarction (STEMI). The Dosage and Administration section of the label recommends initiating treatment as soon as possible after the onset of STEMI symptoms. Alteplase and tenecteplase are marketed and supplied by Genentech in the United States and Canada under the brands Activase and TNKase; and by Boehringer Ingelheim in all other countries except the United States, Canada and Japan under the brands Actilyse® and Metalyse®.
Important Safety Information
- TNKase therapy should not be used in any patients with: active internal bleeding, brain or spinal surgery or a serious head injury within 2 months, a condition that increases your risk of bleeding more than normal, severe uncontrolled high blood pressure, the following conditions due to an increased risk of bleeding (brain tumor, an abnormal connection between veins and arteries in the brain or spinal cord, or abnormal bulge in the wall of an artery). Additional contraindications for the treatment of AIS includes active brain bleeding, and for the treatment of STEMI they include a history of brain bleeding, and a history of ischemic stroke within 3 months.
- Bleeding: TNKase therapy may cause internal bleeding, including bleeding in the brain. Bleeding can also happen from parts of the body where needles have been injected or parts of the body that have had recent surgery. Blood thinners may increase the risk of bleeding if taken before, during, or after TNKase therapy.Bleeding can occur 1 or more days after administration of TNKase. Patients should tell their healthcare provider if they experience signs or symptoms consistent with bleeding (e.g., unusual bruising; pink or brown urine; red, black, or tarry stools; coughing up blood; vomiting blood or blood that looks like coffee grounds) or symptoms of a stroke. Patients should inform their doctor of all prescription and over-the-counter drugs they are currently taking.
- Allergic reaction (hypersensitivity): Allergic reactions including hives and severe or life-threatening allergic reactions can occur very quickly and have been reported after use of TNKase.
- Migrated blood clot (thromboembolism): The use of drugs to help dissolve blood clots can increase the risk of a clot breaking up and migrating in patients with high risk of clots in the left side of the heart, such as those with narrowed heart valves or some abnormal heart rhythms.
- Cholesterol embolization: A plug of cholesterol that blocks an artery (cholesterol embolism) has been reported in patients treated with all types of clot dissolving agents. This is a serious condition which can be lethal.
- Arrhythmias: Irregular heartbeats can also occur after TNKase therapy.
- In patients with serious heart attacks, doctors should choose either drug therapy that dissolves blood clots or a mechanical procedure to open clogged arteries as the main treatment strategy.
- The most common side effect with TNKase therapy is bleeding.
Patients and their caregivers are encouraged to report side effects to Genentech and the FDA. They may contact Genentech by calling 1-888-835-2555. They may contact the FDA by visiting https://www.fda.gov/medwatch or calling 1-800-FDA-1088.
Please see full Prescribing Information for additional Dosing and Administration and Important Safety Information.
For more information, go to https://www.tnkase.com.
About Activase® (alteplase)
Activase® (alteplase) is indicated for treating patients with acute ischemic stroke (sudden stroke), which is caused by a blood clot in the brain’s blood vessels. Patients can receive Activase only if they begin treatment within 3 hours after their stroke symptoms start and only after bleeding in the brain has been ruled out.
Important Safety Information
Who should not be given Activase?
Activase should not be used in patients who have: current bleeding in the brain; bleeding in the area between the brain and the thin tissues that cover the brain; active internal bleeding; recent (within 3 months) brain or spinal surgery or major head trauma; some brain tumor, an abnormal connection between veins and arteries in the brain, or an abnormal bulge in the wall of an artery that supplies blood to the brain; problems with blood clotting; or current severe uncontrolled high blood pressure.
What are the possible serious side effects of Activase?
Bleeding: The most common side effect with Activase is bleeding. Some patients may or may not benefit from Activase because of an increased risk of bleeding, including those with the following conditions: recent major surgery; disease of blood vessels in the brain; recent bleeding in the brain; recent digestive or urinary tract bleeding; recent trauma; uncontrolled high blood pressure; inflammation of the sac around the heart; infection of the inner lining of the heart and the heart valves; increased bleeding risk associated with liver or kidney problems; abnormal liver function; pregnancy; bleeding problems in the eyes; swelling and infection associated with blood clots; elderly patients; patients on blood thinning drugs.
Allergic reaction (hypersensitivity): Allergic reactions including hives and severe or life-threatening allergic reactions can occur very quickly. Rare reports of death from severe allergic reactions have been reported. Swelling of the mouth and throat (angioedema) has been observed in patients treated for sudden stroke (acute ischemic stroke) and sudden heart attack (acute myocardial infarction). This occurred during and up to 2 hours after infusion of Activase. In many cases, patients were also taking angiotensin-converting enzyme inhibitors (a type of medication that can make blood vessels expand).
Migrated blood clot (thromboembolism): The use of drugs to help dissolve blood clots can increase the risk of a clot breaking up and migrating in patients with high risk of clots in the left side of the heart, such as those with narrowed heart valves or some abnormal heart rhythms. Activase has not been shown to adequately treat deep vein blood clot in patients with pulmonary embolism. Blood clots that migrate can cause decreased blood flow to the area that they migrated to. A healthcare provider should evaluate this risk in these patients.
Cholesterol Embolization: A plug of cholesterol that blocks an artery (cholesterol embolism) has been reported rarely in patients treated with all types of clot dissolving agents. This is a serious condition, which can be lethal, and is also associated with invasive medical procedures involving the arteries and veins.
What is the most common side effect with Activase?
The most common side effect with Activase is bleeding.
Patients and their caregivers are encouraged to report side effects to Genentech and the FDA. They may contact Genentech by calling 1-888-835-2555. They may contact the FDA by visiting https://www.fda.gov/medwatch or calling 1-800-FDA-1088.
Please see accompanying full Prescribing Information for Activase for additional important safety information.
About Genentech in Stroke
For decades, Roche and Genentech have been conducting neuroscience research and clinical trials aimed at exploring areas of the highest medical need. We have grown and advanced our neuroscience portfolio to be one of the most diverse and promising in the industry. From the approval of Activase in 1996, the first clot-dissolving medicine approved for the treatment of acute ischemic stroke and the standard-of-care in the United States, Genentech has a long-standing commitment to advancing stroke care.
