Article

FDA Panel Narrowly Rejects Xarelto for ACS

An FDA advisory committee has voted 6-4, with one abstention, against expanding the marketing indications for the factor Xa inhibitor rivaroxaban (Xarelto) to include treatment of acute coronary syndrome (ACS).

The vote by the Cardiovascular and Renal Drugs Advisory Committee was somewhat surprising given the positive review from FDA staff released two days before the meeting, but it signals a growing reluctance to expand indications based on data from a single trial.

Read the full story: http://hcp.lv/Kdov5I

Source: MedPage Today

Newsletter

Stay ahead of policy, cost, and value—subscribe to AJMC for expert insights at the intersection of clinical care and health economics.

Related Videos
Steven Daveluy, MD, dermatologist, Wayne State University
Michael Hassett, MD, MPH, Dana-Farber Cancer Institute
Emilie Aschenbrenner, PharmD, BCOP, Froedtert Health and the Medical College of Wisconsin
AJMC Managed Markets Network Logo
CH LogoCenter for Biosimilars Logo