The FDA issued a complete response letter for Bayer and Johnson & Johnson's potential blockbuster anti-clotting drug Xarelto (rivaroxaban). The agency declined to approved the drug, requesting more data on the therapy. The companies did not detail exactly what additional information the FDA requested.
The good news for Bayer and J&J is that they won't have to run any additional trials of the drug."We are confident in the positive benefit-risk profile of rivaroxaban and will promptly address the questions set forth by the FDA," said Peter DiBattiste, M.D., Vice President, Johnson & Johnson Pharmaceutical Research and Development.
In March, an expert panel voted 15-to-2 in favor of short-term use of Xarelto, which stops blood clots from forming after hip and knee replacements. The companies have a lot riding on its approval. If eventually given the green light for long-term use, Xarelto could replace warfarin, the dominant anti-clotting drug, and bring in up to $6.8 billion in sales for Bayer and J&J.
- here's the release
- read the Reuters report