Johnson & Johnson Faces Uphill Battle At FDA Advisory Panel

The third time could not be the charm. Twice before the FDA has turned down the supplemental new drug application for an acute coronary syndrome indication for Johnson &amp Johnson’s Xarelto (rivaroxaban). On Thursday the Cardiovascular and Renal Medication Advisory Committee will get up the sNDA nevertheless yet again, but FDA assessment documents posted today suggest that the organization will once more face an uphill battle.

Originally, back in 2011, most observers considered the ACS indication would be a snap. The pivotal ATLAS ACS 2-TIMI 51 trial was extensively praised when it came out and the FDA promptly granted priority review for the indication. But  momentum, as I’ve reported before, ground to a halt when FDA reviewers raised queries about the ATLAS trial. The FDA advisory panel, highlighted by vocal criticisms from Steve Nissen and Sanjay Kaul, resulted in a vote against the ACS indication, foremost to the very first comprehensive response letter. The FDA issued a 2nd total response letter final March but J&ampJ restated its self confidence in the trial and its commitment to pursue the indication.

The earlier rejections were based mostly largely on the significant amounts of missing followup information from the trial. The FDA and J&ampJ thought that this difficulty might be circumvented by pursuing an indication for a shorter 90-day remedy duration, given that significantly of the missing information was for longer followup. But the brief phrase information do not seem very convincing and the FDA reviewers make clear in the new assessment paperwork that they now have grave considerations about this technique. (For readers interested in the particulars and minutiae of FDA-sponsor interactions and negotiations, the briefing paperwork include a series of letters from the FDA that supply a fascinating retrospective view of this complicated process.)

There was much more negative news for J&ampJ in the announcement of the panel participants. Former critics Steve Nissen and Sanjay Kaul are on the roster again and will be joined by mentioned pharma critic Sidney Wolfe. In addition, and maybe even more unsafe for J&ampJ, is one of the scheduled FDA presenters, clinical reviewer Thomas Marciniak. He has turn into well recognized for his scathing critiques of rosiglitazone and the angiotensin receptor blockers in addition to rivaroxaban.

Johnson & Johnson Faces Uphill Battle At FDA Advisory Panel