J&J, Bayer try to answer FDA concerns on Xarelto

Bayer and Johnson & Johnson are making another run at getting their anti-clotting drug Xarelto approved for ACS patients, a market that analysts say would take it into blockbuster territory. Johnson & Johnson ($JNJ) has responded to FDA concerns about a clinical study and bleeding risks from Xarelto, Bayer announced today. The agency in June turned down the application to get the drug approved for the prevention of heart attacks or strokes in patients who suffer acute coronary syndrome (ACS). Bayer also said it is asking the FDA to approve the drug for use with standard anti-platelet therapy to reduce the risk of stent thrombosis in patients with ACS, it says in a release. Story | Release