FDA Panel Advises Against Xarelto Approval

Posted on May 24, 2012

Going against the opinion of one of the Food and Drug Administration’s drug reviewers, an advisory panel opted to vote against the approval of a potential blood thinner medication.

The drug in question is called Xarelto (rivaroxaban).  Already on the market for a couple other conditions, its maker was hoping to gain approval to to market the drug for use in preventing blood clots in those individuals who suffer from acute coronary syndrome.  In documents that came to light earlier this week, an FDA drug reviewer advised approval of the drug.  Despite a potential increase in internal bleeding, the reviewer thought that trial data successfully proved a decrease in cardiovascular death.

But an advisory panel that met yesterday disagreed with his conclusions.  In a 6 to 4 vote, they voted against allowing the drug to be marketed in this new way.  They believed that there weren’t sufficient amounts of data which showed the definitive benefit that the product would have.

The panel worried that minor bleeding events weren’t considered in the research conducted to prove the drug’s efficacy.  They thought that, although not necessarily fatal, these events would still require medical treatment that could include rivaroxaban therapy.

Although they voted against approval, that’s not the end of the line.  The FDA will meet and likely make a final decision by June 29.  They are not required to heed the advisory panel.

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