Another FDA delay for Bayer/J&J's Xarelto in ACS indication

There was further negative news for Germany’s Bayer (BAYN: DE) and partner US health care giant Johnson & Johnson (NYSE: JNJ), with the US Food and Drug Administration announcing a further delay in the use of Xarelto (rivaroxaban) for an additional indication.

The FDA issued complete response letters (CRLs) regarding supplemental New Drug Applications (sNDAs) for the use of Xarelto, an oral anticoagulant, to reduce the risk of secondary cardiovascular events – defined as heart attack, stroke or death – in patients with acute coronary syndrome (ACS) and to reduce the risk of stent thrombosis in the same population, in combination with standard antiplatelet therapy.

Already-marketed Xarelto is being developed by Bayer and J&J’s Janssen Research & Development subsidiary. The drug is already approved by the FDA for a number of indications, including the prevention of deep vein thrombosis (DVT) in patients undergoing knee or hip replacement surgery and the treatment of DVT and pulmonary embolism (PE), as well as to reduce the risk of recurrent DVT and PE. Xarelto generated sales of 322 million euros ($440 million) in 2012 and 374 million euros in the first half of 2013 for Bayer, which has forecast peak sales of 2 billion euros for the drug.