FDA Approves Genentech’s TNKase® in Acute Ischemic Stroke in Adults
Genentech, a Roche Group member (RHHBY), has received FDA approval for TNKase® (tenecteplase) to treat acute ischemic stroke (AIS) in adults, marking the first stroke medicine approval in nearly 30 years. TNKase is administered as a single five-second intravenous bolus, offering faster and simpler administration compared to the current standard-of-care Activase® (alteplase).
This approval makes Genentech the developer of the only two FDA-approved medicines for AIS treatment. The company plans to introduce a new 25 mg vial configuration in the coming months. The approval is supported by the AcT trial, a multi-center non-inferiority study conducted across 22 Canadian stroke centers, demonstrating TNKase's comparable safety and efficacy to Activase.
Stroke remains the fifth leading cause of death and the primary cause of long-term disability in the United States, affecting over 795,000 people annually. TNKase is also FDA-approved for treating acute ST-elevation myocardial infarction (STEMI) in adults.
Genentech, un membro del gruppo Roche (RHHBY), ha ricevuto l' Questa approvazione rende Genentech lo sviluppatore degli unici due farmaci approvati dalla FDA per il trattamento dell'AIS. L'azienda prevede di introdurre una nuova configurazione da 25 mg nei prossimi mesi. L'approvazione è supportata dallo studio AcT, uno studio multicentrico di non inferiorità condotto in 22 centri per ictus in Canada, che dimostra la sicurezza e l'efficacia comparabili di TNKase rispetto ad Activase. L'ictus rimane la quinta causa di morte e la principale causa di disabilità a lungo termine negli Stati Uniti, colpendo oltre 795.000 persone ogni anno. TNKase è anche approvato dalla FDA per il trattamento dell'infarto miocardico acuto con elevazione del segmento ST (STEMI) negli adulti.
Genentech, un miembro del grupo Roche (RHHBY), ha recibido la aprobación de la FDA para TNKase® (tenecteplasa) para tratar el accidente cerebrovascular isquémico agudo (AIS) en adultos, marcando la primera aprobación de un medicamento para el accidente cerebrovascular en casi 30 años. TNKase se administra como un único bolo intravenoso de cinco segundos, ofreciendo una administración más rápida y simple en comparación con el estándar de atención actual Activase® (alteplasa).
Esta aprobación convierte a Genentech en el desarrollador de los únicos dos medicamentos aprobados por la FDA para el tratamiento del AIS. La compañía planea introducir una nueva configuración de vial de 25 mg en los próximos meses. La aprobación está respaldada por el ensayo AcT, un estudio multicéntrico de no inferioridad realizado en 22 centros de accidente cerebrovascular en Canadá, que demuestra la seguridad y eficacia comparables de TNKase en comparación con Activase.
El accidente cerebrovascular sigue siendo la quinta causa principal de muerte y la principal causa de discapacidad a largo plazo en los Estados Unidos, afectando a más de 795,000 personas anualmente. TNKase también está aprobado por la FDA para el tratamiento del infarto de miocardio agudo con elevación del segmento ST (STEMI) en adultos.
제넨텍(Genentech), 로슈 그룹(Roche Group) 소속(주식 코드: RHHBY),은 성인에서 급성 허혈성 뇌졸중(AIS) 치료를 위한 TNKase®(테넥테플라제)에 대해 FDA 승인을 받았으며, 이는 거의 30년 만에 첫 번째 뇌졸중 약물 승인을 의미합니다. TNKase는 단일 5초 정맥 주사로 투여되며, 현재 표준 치료제인 Activase®(알테플라제)보다 더 빠르고 간편한 투여 방법을 제공합니다.
이번 승인은 제넨텍이 AIS 치료를 위해 FDA 승인을 받은 유일한 두 가지 약물의 개발자가 되게 합니다. 회사는 향후 몇 달 내에 25mg 바이알 구성을 도입할 계획입니다. 이 승인은 캐나다의 22개 뇌졸중 센터에서 실시된 다기관 비열등성 연구인 AcT 시험에 의해 뒷받침되며, TNKase의 Activase와의 안전성과 효능이 동등함을 보여줍니다.
뇌졸중은 미국에서 다섯 번째로 큰 사망 원인이며, 장기적인 장애의 주요 원인으로 매년 795,000명 이상에게 영향을 미칩니다. TNKase는 성인에서 급성 ST 분절 상승 심근경색(STEMI) 치료를 위해서도 FDA 승인을 받았습니다.
Genentech, membre du groupe Roche (RHHBY), a reçu l'
Cette approbation fait de Genentech le développeur des deux seuls médicaments approuvés par la FDA pour le traitement de l'AIS. L'entreprise prévoit d'introduire une nouvelle configuration de flacon de 25 mg dans les mois à venir. L'approbation est soutenue par l'essai AcT, une étude multicentrique de non-infériorité réalisée dans 22 centres canadiens de traitement des AVC, démontrant la sécurité et l'efficacité comparables de TNKase par rapport à Activase.
L'accident vasculaire cérébral reste la cinquième cause de décès et la principale cause de handicap à long terme aux États-Unis, touchant plus de 795 000 personnes chaque année. TNKase est également approuvé par la FDA pour le traitement de l'infarctus du myocarde aigu avec élévation du segment ST (STEMI) chez les adultes.
Genentech, ein Mitglied der Roche-Gruppe (RHHBY), hat die FDA-Zulassung für TNKase® (Tenecteplase) zur Behandlung von akutem ischämischem Schlaganfall (AIS) bei Erwachsenen erhalten, was die erste Zulassung eines Schlaganfallmedikaments seit fast 30 Jahren markiert. TNKase wird als einmaliger intravenöser Bolus über fünf Sekunden verabreicht und bietet eine schnellere und einfachere Verabreichung im Vergleich zum aktuellen Standardbehandlungsprodukt Activase® (Alteplase).
Diese Zulassung macht Genentech zum Entwickler der einzigen zwei von der FDA zugelassenen Medikamente zur Behandlung von AIS. Das Unternehmen plant, in den kommenden Monaten eine neue 25 mg Fläschchenkonfiguration einzuführen. Die Zulassung wird durch die AcT-Studie unterstützt, eine multizentrische Nichtunterlegenheitsstudie, die in 22 kanadischen Schlaganfallzentren durchgeführt wurde und die vergleichbare Sicherheit und Wirksamkeit von TNKase im Vergleich zu Activase zeigt.
Der Schlaganfall bleibt die fünft häufigste Todesursache und die Hauptursache für langfristige Behinderungen in den Vereinigten Staaten und betrifft jährlich über 795.000 Menschen. TNKase ist auch von der FDA zur Behandlung von akutem ST-Hebungsmyokardinfarkt (STEMI) bei Erwachsenen zugelassen.
- First new stroke treatment approval in 30 years
- Faster and simpler administration compared to current standard
- Expanded market opportunity in stroke treatment
- Additional indication beyond existing STEMI approval
- New product may cannibalize existing Activase sales
- Requires new vial configuration implementation
– TNKase® (tenecteplase) is the first stroke medicine approved by the FDA in nearly 30 years –
– Single five-second intravenous bolus provides faster and simpler administration than the approved standard-of-care –
– Genentech has developed the only two FDA-approved medicines to treat acute ischemic stroke, 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 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
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
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.
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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
About Genentech
Founded more than 40 years ago, Genentech is a leading biotechnology company that discovers, develops, manufactures and commercializes medicines to treat patients with serious and life-threatening medical conditions. The company, a member of the Roche Group, has headquarters in
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FAQ
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