Seeking Alpha

FDA unconvinced by J&J's Xarelto for heart attack patients

  • The FDA expresses skepticism that Johnson & Johnson's (JNJ) anticoagulant Xarelto (rivaroxaban) is effective in cutting the risk of additional heart problems in heart-attack patients.
  • J&J has recommended that Xarelto, which is already authorized for other uses, be administered in the 90 days after an attack.
  • However, the FDA doesn't see the point. "Not only does the effect of rivaroxaban not appear to be greater earlier, but an effect in the first 90 days or so is not apparent at all," the agency says in a review.
  • The FDA's comments come two days before an advisory panel is due to discuss whether to recommend Xarelto for this indication.
  • Bayer (BAYRY) co-markets Xarelto.
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