Low-Dose Xarelto Effective In ACS Patients
This article was originally published in The Pink Sheet Daily
Bayer and J&J tout positive results from a Phase III study of Xarelto in a new patient population, while Eliquis hits a setback.
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FDA will ask its cardio-renal advisory committee whether missing data in J&J/Bayer’s ATLAS study affects the interpretability of rivaroxaban’s demonstrated efficacy in acute coronary syndromes. The panel also will be asked whether the agency should pre-specify clinical trial standards for data quality to reduce the problems associated with missing data in CV outcomes studies.
J&J’s defense of its pending stroke prevention indication in atrial fibrillation for Xarelto at the September 8 FDA Cardio-Renal Advisory Committee is likely to go down in FDA lore as an example of a successful argument that saved an application, but not the product. The presentation may also be notable into the future for two slides on benefit/risk which address one of FDA’s new interests: patient preferred outcomes.