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Regulatory Focus™ > News Articles > Advisory Committee Votes Against Label Expansion for J&J/Bayer's Xarelto

Advisory Committee Votes Against Label Expansion for J&J/Bayer's Xarelto

Posted 24 May 2012 | By Alexander Gaffney, RAC 

The US Food and Drug Administration's (FDA) Cardiovascular and Renal Drugs Advisory Committee voted against Johnson & Johnson and Bayer's co-developed oral anticoagulant drug Xarelto (rivaroxaban), which the companies were looking to market as a therapy for Acute Coronary Syndrome (ACS).

Xarelto is already FDA-approved for reducing the risk of blood clots in limited populations.

The advisory committee had expressed some doubts regarding the drug on 22 May, saying missing data and several uncounted deaths among the data could be "the tip of the iceberg" for further problems. An FDA medical reviewer, Karen Hicks, had nevertheless supported the product, saying it exhibited a net benefit in patients "despite an increased risk of major and fatal bleeding."

The advisory committee members appeared to err on the side of the missing data during their 23 May meeting, voting 6-4 against the approval of 2.5 mg twice-daily Xarelto for ACS, with one member abstaining.

Led by Cleveland Clinic cardiologist and advisory committee member Steven Nissen, the committee frequently referred to the "missingness" of the data, reports Forbes.

In a statement, Johnson & Johnson appeared to be relatively un-phased by the committee's vote.

"We appreciate the thoroughness of the committee's review, and will ensure the questions raised today are addressed with the FDA," said Paul Burton, MD, PhD, Vice President, Cardiovascular Franchise Medical Leader at Johnson & Johnson subsidiary Janssen.

Forbes reports several committee participants, including FDA's Robert Temple, thought FDA might ultimately approve Xarelto, and would likely do so at the 2.5 mg dosage point. "I would not be shocked if this were to happen," remarked Larry Husten, editor of CardioBrief.

Read (much) more:

Forbes - Live Blog: The FDA Advisory Panel For Rixaroxaban for ACS

J&J - FDA Advisory Committee Recommends Against Approval of Oral Anticoagulant XARELTO® to Reduce the Risk of Secondary Cardiovascular Events in Patients with Acute Coronary Syndrome

Reuters - U.S. advisers reject J&J/Bayer's Xarelto for acute coronary patients

The New York Times - F.D.A. Panel Votes Against Expanding Use of an Anticoagulant

The Pink Sheet Daily - ATLAS Data Not Strong Enough To Support Xarelto's Use In ACS, FDA Panel Says

MedPage Today - FDA Panel Narrowly Rejects Xarelto for ACS

The Boston Herald - FDA panel votes against new use for J&J's Xarelto

Pharmalot - FDA Panel Nixes J&J And Bayer's Xarelto

Pharma Times - FDA panel votes against Bayer's Xarelto for ACS, regorafenib filed

BioCentury - Panel recommends against Xarelto for ACS

PMLiVE - FDA advisory panel turns down Xarelto for ACS

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