An expert FDA panel has voted 15-to-2 in favor of short-term use of Xarelto (rivaroxaban), which is being developed by Bayer and Johnson & Johnson. Xarelto stops blood clots from forming after hip and knee replacements. The news sent Bayer's stock soaring 6.9 percent this morning.
The drug has already been approved for short-term use in Europe, and approval for that indication in the U.S. could bring in hundreds of millions in sales. However, Xarelto is projected to bring in as much as $6.8 billion in annual sales if approved for long-term use. "The real money lies in treating millions of chronic patients for stroke prevention and post-acute coronary syndrome," Rick Wise, an analyst with Leerink Swann, told The New York Times. The companies are still awaiting trial data on long-term use of the drug, which is expected in 2010.
If approved for long-term use, Xarelto could supplant warfarin, the dominant anti-clotting drug. In clinical trials, Xarelto was better than a comparative drug at preventing blood clots but increased major bleeding incidents among the patients taking the therapy. Undoubtedly, FDA will carefully consider risk-benefit ratio before approving Xarelto for long-term use.
- here's the report from Forbes
- see the New York Times article