The U.K.'s National Institute for Health and Care Excellence has recommended the use of rivaroxaban, or Xarelto, to prevent blood clots following acute coronary syndrome. The final draft guidance says that providers should assess bleeding risks before beginning treatment.
An FDA staff review has expressed doubts about Johnson & Johnson's application for the anticoagulant Xarelto, or rivaroxaban, as a treatment for acute coronary syndrome. There was no convincing evidence that Xarelto is superior to existing drugs or addresses an unmet medical need, reviewers said. An official from Janssen Research & Development, a J&J unit, said that, in combination with standard therapies, Xarelto "delivers a strong incremental benefit by significantly reducing the risk of cardiovascular events, including death, at a time when patients are at the highest risk."
Bayer and Johnson & Johnson are initiating two late-stage trials of the anticoagulant rivaroxaban after failing to get expanded FDA approval for the prevention of cardiovascular events in patients with acute coronary syndrome. One trial will involve individuals with chronic heart failure and significant coronary artery disease. The other will include patients with nonvalvular atrial fibrillation.
Health Canada issued a public advisory about the possibility of serious skin reactions with the hepatitis C treatment Incivek from Vertex Pharmaceuticals. The move comes two months after the FDA released a similar warning.
An FDA advisory panel voted against expanding approval of rivaroxaban for patients with acute coronary syndrome. Bleeding risks were among the concerns raised by panel members, and a final ruling from the FDA is expected by the end of June.