Setback for Janssen and Bayer's Xarelto as FDA calls for more info in stent thrombosis setting for ACS patients

1 July 2013

Janssen Research & Development, a unit of US health care giant Johnson & Johnson (NYSE: JNJ) revealed on Friday (June 28) that US Food and Drug Administration has issued a complete response letter for the supplemental New Drug Application (sNDA) for Xarelto (rivaroxaban) - partnered with German drug major Bayer (BAYN: DE) - to reduce the risk of stent thrombosis in patients with acute coronary syndrome (ACS).

The news had little impact on the shares of the two companies, which both dipped just around 0.3% to $86.44 and 81.93 euros, respectively on Friday.

"We remain confident in the results of the ATLAS ACS 2 TIMI 51 trial and are in ongoing discussions with the FDA regarding this sNDA," said Christopher Nessel, vice president, cardiovascular franchise medical leader at Janssen, without giving any indication of what further information the US regulator had requested.

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