By Jennifer Lilonsky ( | First Posted: Mar 05, 2013 04:45 PM EST

(Photo : Reuters )

The U.S. Food and Drug Administration has rejected a new drug application for Johnson & Johnson's Xarelto acute coronary syndrome indication for the second time.

The proposed indication for Xarelto, or rivaroxaban, is to be used in treating patients with acute coronary syndrome, ACS, and despite receiving acclaim in 2011 after the unveiling of the ATLAS ACS 2-TIMI 51 trial, the drug has been road blocked by the FDA's Cardiovascular and Renal Drugs Advisory Committee.

The drug in question has been approved for preventing clots after knee and hip replacement surgeries, as well as for the prevention of strokes and blood clots in patients with atrial fibrillation.

And the proposed ACS drug also showed some signs of excelling following an FDA-granted priority review for the drug indication in February 2012, but that proved to be fleeting after FDA reviewers raised concern over the ATLAS trial. As a result of the speculation, the ACS indication was rejected by a vote from the Cardiovascular and Renal Drugs Advisory Committee.

The government agency first responded to the rejection of the new drug application last June in a written statement.

But Johnson & Johnson remained steadfast in their support of Xarelto.

The company issued a press release following the rejection in June 2012 and said that they are "confident in the robust results of the ATLAS ACS 2 TIMI 51 trial and the positive benefit-risk profile of rivaroxaban in patients with ACS. We will continue to work with the FDA to fully address their questions as quickly as possible."

And Johnson & Johnson released a new press release Monday that summarizes their continual backing of the ACS indication for Xarelto and that provides more information about the ATLAS trial that the FDA and its advisory panel criticized for missing data.


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