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ATLAS Trial Design Blamed For Missing Data On Xarelto ACS Use

 
• By Sue Sutter

Some members of FDA’s Cardiovascular and Renal Drugs Advisory Committee questioned whether the high rate of study dropouts and consent withdrawals in rivaroxaban’s pivotal trial for acute coronary syndromes resulted from elements of the trial’s design, including patient consent and follow-up procedures and the primary analysis.

Elements of the ATLAS clinical trial’s protocol and design may have undermined the quality and amount of data supporting use of Johnson & Johnson/Bayer HealthCare AG’s Xarelto (rivaroxaban) for acute coronary syndromes, members of FDA’s Cardiovascular and Renal Drugs Advisory Committee said.

During their May 23 review of an ACS indication, panelists questioned whether the sponsors could have done more to prevent...

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The transparency initiative collects CRLs already made public in approval packages on its drugs@fda site to post on the openFDA public portal.

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US FDA’s CRL Release More Incremental Than ‘Radical’ Transparency

 
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The transparency initiative collects CRLs already made public in approval packages on its drugs@fda site to post on the openFDA public portal.

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