Evaluating Rivaroxaban for Nonvalvular Atrial Fibrillation — Regulatory Considerations
An FDA advisory committee recently considered a new drug application for rivaroxaban for preventing stroke and systemic embolism in patients with nonvalvular atrial fibrillation, but there are important concerns about interpretation of the results of the key study. On September 8, 2011, the Cardiova...
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| Veröffentlicht in: | The New England journal of medicine 2011-10, Vol.365 (17), p.1557-1559 |
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| creator | Fleming, Thomas R Emerson, Scott S |
| description | An FDA advisory committee recently considered a new drug application for rivaroxaban for preventing stroke and systemic embolism in patients with nonvalvular atrial fibrillation, but there are important concerns about interpretation of the results of the key study.
On September 8, 2011, the Cardiovascular and Renal Drugs Advisory Committee of the Food and Drug Administration (FDA) discussed data submitted in support of the new drug application for rivaroxaban for preventing stroke and non–central nervous system systemic embolic events in patients with nonvalvular atrial fibrillation. Supportive evidence came primarily from ROCKET-AF (Rivaroxaban Once Daily Oral Direct Factor Xa Inhibition Compared with Vitamin K Antagonism for Prevention of Stroke and Embolism Trial in Atrial Fibrillation; ClinicalTrials.gov number, NCT00403767),
1
in which more than 14,000 patients were randomly assigned in a double-blind fashion to either 20 mg of rivaroxaban once daily or . . . |
| doi_str_mv | 10.1056/NEJMp1110639 |
| format | Article |
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On September 8, 2011, the Cardiovascular and Renal Drugs Advisory Committee of the Food and Drug Administration (FDA) discussed data submitted in support of the new drug application for rivaroxaban for preventing stroke and non–central nervous system systemic embolic events in patients with nonvalvular atrial fibrillation. Supportive evidence came primarily from ROCKET-AF (Rivaroxaban Once Daily Oral Direct Factor Xa Inhibition Compared with Vitamin K Antagonism for Prevention of Stroke and Embolism Trial in Atrial Fibrillation; ClinicalTrials.gov number, NCT00403767),
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On September 8, 2011, the Cardiovascular and Renal Drugs Advisory Committee of the Food and Drug Administration (FDA) discussed data submitted in support of the new drug application for rivaroxaban for preventing stroke and non–central nervous system systemic embolic events in patients with nonvalvular atrial fibrillation. Supportive evidence came primarily from ROCKET-AF (Rivaroxaban Once Daily Oral Direct Factor Xa Inhibition Compared with Vitamin K Antagonism for Prevention of Stroke and Embolism Trial in Atrial Fibrillation; ClinicalTrials.gov number, NCT00403767),
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in which more than 14,000 patients were randomly assigned in a double-blind fashion to either 20 mg of rivaroxaban once daily or . . .</description><subject>Advisory Committees</subject><subject>Anticoagulants</subject><subject>Anticoagulants - therapeutic use</subject><subject>Atrial Fibrillation - drug therapy</subject><subject>Clinical trials</subject><subject>Clinical Trials as Topic</subject><subject>Confidence intervals</subject><subject>Drug Approval - legislation & jurisprudence</subject><subject>Drug therapy</subject><subject>Embolism</subject><subject>Fibrillation</subject><subject>Government Regulation</subject><subject>Humans</subject><subject>Morpholines - therapeutic use</subject><subject>Rivaroxaban</subject><subject>Stroke</subject><subject>Thiophenes - therapeutic use</subject><subject>United States</subject><subject>United States Food and Drug Administration</subject><issn>0028-4793</issn><issn>1533-4406</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2011</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><sourceid>ABUWG</sourceid><sourceid>AFKRA</sourceid><sourceid>AZQEC</sourceid><sourceid>BEC</sourceid><sourceid>BENPR</sourceid><sourceid>CCPQU</sourceid><sourceid>DWQXO</sourceid><sourceid>GNUQQ</sourceid><sourceid>GUQSH</sourceid><sourceid>M2O</sourceid><recordid>eNptkE9LwzAYh4Mobk5vniWI4MVq0iRtcxxj8w9zwlDwVpI2HR1tMpN2uJsfwk_oJzFzU0R8L-_h9_Dwvj8AjjG6xIhFV5Ph3f0CY4wiwndAFzNCAkpRtAu6CIVJQGNOOuDAuTnygynfB50Qcx5SzrrgebgUVSuaUs_gtFwKa16FFBoWxsKJ0T5ctpWwsN_YUlRwVEpbVpXnjYYfb-9wqmY-b4xdwYHRrsyV_QrdIdgrROXU0Xb3wNNo-Di4CcYP17eD_jjICI2aIOShpIWIYi5llscZkowy_wJhScy5UigsEoaplEJEmBWxwplMMp4TUSQoyQnpgfONd2HNS6tck9aly5S_USvTupQjjBAlKPHk6R9yblqr_XEeQgmOWLTWXWygzBrnrCrShS1rYVcpRum67_R33x4_2TpbWav8B_4u2ANnG6CuXarVvP7f8wmwBYce</recordid><startdate>20111027</startdate><enddate>20111027</enddate><creator>Fleming, Thomas R</creator><creator>Emerson, Scott S</creator><general>Massachusetts Medical Society</general><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>0TZ</scope><scope>7RV</scope><scope>7X7</scope><scope>7XB</scope><scope>8AO</scope><scope>8C1</scope><scope>8FE</scope><scope>8FH</scope><scope>8FI</scope><scope>ABUWG</scope><scope>AFKRA</scope><scope>AN0</scope><scope>AZQEC</scope><scope>BBNVY</scope><scope>BEC</scope><scope>BENPR</scope><scope>BHPHI</scope><scope>CCPQU</scope><scope>DWQXO</scope><scope>FYUFA</scope><scope>GHDGH</scope><scope>GNUQQ</scope><scope>GUQSH</scope><scope>HCIFZ</scope><scope>K0Y</scope><scope>LK8</scope><scope>M0R</scope><scope>M0T</scope><scope>M1P</scope><scope>M2M</scope><scope>M2O</scope><scope>M2P</scope><scope>M7P</scope><scope>MBDVC</scope><scope>NAPCQ</scope><scope>PQEST</scope><scope>PQQKQ</scope><scope>PQUKI</scope><scope>PRINS</scope><scope>PSYQQ</scope><scope>Q9U</scope><scope>7X8</scope></search><sort><creationdate>20111027</creationdate><title>Evaluating Rivaroxaban for Nonvalvular Atrial Fibrillation — Regulatory Considerations</title><author>Fleming, Thomas R ; 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On September 8, 2011, the Cardiovascular and Renal Drugs Advisory Committee of the Food and Drug Administration (FDA) discussed data submitted in support of the new drug application for rivaroxaban for preventing stroke and non–central nervous system systemic embolic events in patients with nonvalvular atrial fibrillation. Supportive evidence came primarily from ROCKET-AF (Rivaroxaban Once Daily Oral Direct Factor Xa Inhibition Compared with Vitamin K Antagonism for Prevention of Stroke and Embolism Trial in Atrial Fibrillation; ClinicalTrials.gov number, NCT00403767),
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| source | MEDLINE; New England Journal of Medicine Current; EZB-FREE-00999 freely available EZB journals; ProQuest Central UK/Ireland |
| subjects | Advisory Committees Anticoagulants Anticoagulants - therapeutic use Atrial Fibrillation - drug therapy Clinical trials Clinical Trials as Topic Confidence intervals Drug Approval - legislation & jurisprudence Drug therapy Embolism Fibrillation Government Regulation Humans Morpholines - therapeutic use Rivaroxaban Stroke Thiophenes - therapeutic use United States United States Food and Drug Administration |
| title | Evaluating Rivaroxaban for Nonvalvular Atrial Fibrillation — Regulatory Considerations |
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