Janssen Faces Prospect Of New Trial For Xarelto ACS Claim
Cardio-renal advisory committee recommends against rivaroxaban’s approval for acute coronary syndromes and says exploratory analyses on duration of use could be used to design a new study. Panelists also had some thoughts on whether, and how, to study anticoagulants for acute treatment and chronic use together.
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As the platelet inhibitor heads to an advisory committee, agency reviewers raise issues about safety-based changes to its Phase III trials.
ATLAS Data Not Strong Enough To Support Xarelto’s Use In ACS, FDA Panel Says
Six of 11 members of the Cardiovascular and Renal Drugs Advisory Committee voted against rivaroxaban’s approval for acute coronary syndromes, saying concerns about missing data in the pivotal trial raised doubts about the efficacy results and could not support creating a new standard of care by adding the Factor Xa inhibitor to dual-antiplatelet therapy.
Electronic Records: US FDA Updates Guidelines On Use In Clinical Investigations
Revised draft guidance includes recommendations on preparing for FDA inspections, considerations for real-world data and digital health technologies, and the need for service level agreements between sponsors and IT providers.