J&J Saves Xarelto; But Faces tough Label

J&J’s defense of its pending stroke prevention indication in atrial fibrillation for Xarelto at the September 8 FDA Cardio-Renal Advisory Committee is likely to go down in FDA lore as an example of a successful argument that saved an application, but not the product. The presentation may also be notable into the future for two slides on benefit/risk which address one of FDA’s new interests: patient preferred outcomes.