2月14日，Johnson & Johnson收到FDA的完全答复函，FDA拒绝批准利伐沙班增加适应症用于急性冠脉综合征。今年1月16日，FDA咨询委员会以10:0全票否决了该sNDA，认为ATLAS试验数据不足以支持上市，特别是在部分数据丢失的情况下。目前该药已获批用于深静脉血栓、肺动脉栓塞、减少血液凝块及降低卒中风险。
FDA Issues Complete Response Letters for Use of XARELTO®(rivaroxaban) to Reduce the Risk of Secondary Cardiovascular Events and Stent Thrombosis in Patients with Acute Coronary Syndrome
Raritan, NJ (February 14, 2014) — Janssen Research & Development, LLC (Janssen) announced today the U.S. Food and Drug Administration (FDA) issued complete response letters (CRLs) regarding supplemental New Drug Applications (sNDAs) for the use of XARELTO® (rivaroxaban), an oral anticoagulant, to reduce the risk of secondary cardiovascular events – defined as heart attack, stroke or death – in patients with acute coronary syndrome (ACS) and to reduce the risk of stent thrombosis in the same population, in combination with standard antiplatelet therapy.
“We remain committed to providing patients who have suffered from acute coronary syndrome with additional protection against stent thrombosis and secondary life-threatening cardiovascular events,” said Paul Burton, M.D., Ph.D., Vice President, Clinical Development, Janssen Research & Development. “We are evaluating the contents of the letters and will determine the appropriate next steps.”
ACS is a complication of coronary heart disease, which is the leading cause of death in the U.S. and one of the most prevalent non-communicable diseases in the world. ACS occurs when a blood clot blocks a coronary artery, reducing blood supply to the heart. This disruption of blood flow can cause a heart attack or unstable angina, a condition signifying that a heart attack may soon occur. Each year, an estimated 1.2 million patients in the U.S. are discharged from the hospital with a diagnosis of ACS. About 785,000 Americans have a first heart attack each year, while another 470,000 who have already experienced one or more heart attacks go on to have another attack.
Stent thrombosis is an uncommon, but potentially catastrophic complication that may occur after a stent has been inserted into a patient’s coronary artery and causes clots to form. If blood flow is significantly restricted or completely blocked, this can result in unstable angina, myocardial infarction or even death, with incident rates as high as 64 percent. Survivors of a stent thrombosis event are at an elevated risk of recurrent stent thrombosis.
Both sNDAs are based on results from the 15,526-patient pivotal Phase 3 ATLAS ACS 2 TIMI 51 (®, which was presented at the American Heart Association’s annual Scientific Sessions and published in the New England Journal of Medicine in November 2011.
® (rivaroxaban) XARELTO® works by blocking the blood clotting Factor Xa and does not require routine blood monitoring. XARELTO® has the broadest indication profile of any oral anticoagulant and is approved for six indications that include:
To reduce the risk of strokes and blood clots in patients with atrial fibrillation not caused by a heart valve problem. For patients currently well managed on warfarin, there is limited information on how XARELTO® and warfarin compare in reducing the risk of stroke.
To treat patients with deep vein thrombosis (DVT).
To treat patients with pulmonary embolism (PE).
To reduce the risk of recurrence of DVT or PE following an initial six-month treatment for acute venous thromboembolism.
To reduce the risk of blood clots in the legs and lungs of patients who have just had knee replacement surgery.
To reduce the risk of blood clots in the legs and lungs of patients who have just had hip replacement surgery.
The extensive program of clinical trials evaluating rivaroxaban makes the compound the most studied oral Factor Xa inhibitor in the world today. By the time of its completion in 2018, approximately 100,000 patients will have participated in the rivaroxaban clinical development program.
Janssen Research & Development, LLC and Bayer HealthCare together are developing rivaroxaban.
For more information about XARELTO®, visit www.xarelto-us.com. The XARELTO® CarePath™ Support Program is a resource designed for healthcare providers, patients and caregivers. Visit www.xareltocarepath.com or call 1-888-XARELTO to learn more about the XARELTO®CarePath™ resources focused on access, education and adherence.
XARELTO® is a prescription medicine used to reduce the risk of stroke and blood clots in people with atrial fibrillation, not caused by a heart valve problem. For patients currently well managed on warfarin, there is limited information on how XARELTO® and warfarin compare in reducing the risk of stroke.
XARELTO® is also a prescription medicine used to treat deep vein thrombosis and pulmonary embolism, and to help reduce the risk of these conditions occurring again.
XARELTO® is also a prescription medicine used to reduce the risk of forming a blood clot in the legs and lungs of people who have just had knee or hip replacement surgery.
关键词： FDA 强生 XARELTO 利伐沙班 适应症 急性冠脉综合征
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