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.
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.
Agency wants to ensure patients ‘aren’t unnecessarily or unfairly scared off or intimidated’ from taking biosimilars, Office of Therapeutic Biologics and Biosimilars' acting policy director Eva Temkin tells the FDA/CMS Summit; Temkin says recent guidance on biosimilar insulins shows agency is trying to be flexible on interchangeability data requirements.