Johnson & Johnson ($JNJ) and Bayer's blockbuster candidate Xarelto just won access to a new market--one that could eventually account for about $600 million in sales. It's just the latest in a series of indications added to the clot fighter's label.
Already FDA-approved for stroke prevention in patients with atrial fibrillation, as well as clot prevention in certain surgery patients, the drug can now be marketed to treat and prevent clots in the legs and lungs. Xarelto is one in a new generation of anticoagulants, designed to be alternatives to the old standard, warfarin.
The FDA's backing is a victory for Xarelto, which lost out in June on a big new indication. The agency declined to approve it as a preventive in patients with acute coronary syndrome, a potentially enormous market. J&J recently submitted new data and is looking for a response early next year.
If Xarelto performs as J&J and Bayer hope, it will be a multibillion-dollar seller for both companies. In this latest group of patients, it has the potential to change the standard of care, one researcher said. "Venous blood clots are associated with a high risk of serious complications, so the approval of Xarelto will immediately impact how we treat these patients," New York University School of Medicine Professor Jack Ansell said in a J&J statement.
FDA announced the new indication on the same day as news about Xarelto's head-to-head rival, Pradaxa. That drug, sold by Boehringer Ingelheim, has been under review for safety, after patients using it experienced serious bleeding and hundreds died. FDA concluded that rates of bleeding were no greater in Pradaxa patients than in warfarin patients.
- get the FDA release
- see the J&J announcement
- see the Bloomberg story