Regulatory Focus™ > News Articles > Reviewers Express Doubts in Advance of Xarelto Review

Reviewers Express Doubts in Advance of Xarelto Review

Posted 22 May 2012 | By Alexander Gaffney, RAC 

An advisory committee to the US Food and Drug Administration (FDA) gave US-based manufacturer Johnson & Johnson's (J&J) blood thinner Xarelto (rixaroxaban), experimentally used to treat acute coronary syndrome (ACS), mixed reviews after taking issue with the quality of data used to support the drug.

CNBC reports the panel of advisors was particularly troubled by missing data, including 12% of patients in the study and several deaths which were not counted in J&J's presentation of data.  "These three uncounted deaths may be the tip of the iceberg regarding problems with missing data," said Dr. Thomas Marciniak, a medical team leader at FDA.

Reuters explains other reviews on the Cardiovascular and Renal Drugs Advisory Committee expressed doubts as to whether Xarelto "reduced the risk of death in patients with ACS." The doubts could be a troubling sign for J&J in advance of the committee's 23 May vote on whether to recommend Xarelto for the treatment of ACS.

The company, which co-developed the drug with German-headquartered Bayer AG, did receive the support of an FDA medical reviewer, Karen Hicks, who said the product appeared to have a "favorable" benefit risk ratio "despite an increased risk of major and fatal bleeding."

Read more:

CNBC - FDA staff sends mixed message on J&J drug Xarelto

Reuters - Missing data raise doubts on J&J drug-US FDA staff

Bloomberg - J&J-Bayer Xarelto's Use in Prevention Is Effective, FDA Says

MedPage Today - FDA Staff Likes Xarelto for ACS

The Pink Sheet - Xarelto Acute Coronary Syndromes Claim Faces Data Quality Hurdle

Regulatory Focus newsletters

All the biggest regulatory news and happenings.