Xarelto gets boost from FDA

Despite the upcoming July 4 holiday weekend, FDA officials were busy Friday. In addition to approving a Novartis drug, they gave good news to Johnson & Johnson and Bayer Healthcare with the approval of Xarelto (rivaroxaban tablets), a novel, once-daily, oral anticoagulant for the prevention of deep vein thrombosis, which may lead to a pulmonary embolism in people undergoing knee or hip replacement surgery.

The news is the latest in the blood-clot drug race. Pfizer and Bristol-Myers Squibb's Eliquis, the yet-to-be-approved drug, recently aced a late-stage trial, performing far beyond analysts' expectations. The drug was more effective at preventing strokes than the old standby warfarin--and safer, too. That means Eliquis patients were less likely to develop bleeding problems than those using the older drug. Xarelto is equivalent to--not better than--warfarin on safety and efficacy, as Forbes has noted. But it is a once-a-day drug.

As Bloomberg notes, Xarelto may generate as much as $1.6 billion in annual sales in the U.S., according to Citigroup's Matthew Dodds. This number includes $100 million for the newly approved use--treating the 1.2 million Americans who have hip and knee surgery each year. The product may generate $1.2 billion from treating the 2.5 million Americans with atrial fibrillation, he added, as quoted by Bloomberg. The approval is a victory for J&J and Bayer, but the pair is hoping for additional regulatory approvals for more uses of the drug, as the Wall Street Journal notes.

"Shorter hospital stays following hip and knee replacement surgeries have made the prevention of venous blood clots an outpatient issue, and Xarelto provides a safe and effective oral treatment option that can be easily transitioned from use in hospital to home," said Paul Chang, VP of medical affairs, internal medicine, Janssen Pharmaceuticals. "We're pleased to make Xarelto tablets available to physicians to help them better protect their patients from these highly preventable surgical complications."

- see the J&J release
- get more from Bloomberg
- check out more from the WSJ