An FDA advisory panel recommended giving a thumbs down to Johnson & Johnson/Bayer’s anticoagulant Xarelto (rivaroxaban) for use in patients with atrial fibrillation (AF). Briefing documents released ahead of a vote show the main issue is that data from the phase III Rocket trial comparing rivaroxaban to warfarin are not adequate to determine whether the agent is as effective vs. warfarin when the latter is used skillfully. The panel’s vote this Thursday won’t be binding on the FDA. It’s possible the agency will end up approving Xarelto as second-line therapy in a more restricted patient population, or reject it, analysts said. Either way, it appears Xarelto will be at a disadvantage to Boehringer Ingelheim’s Pradaxa, already approved, and to Pfizer/Bristol-Myers Squibb’s Eliquis (apixaban), expected to reach market next year.
Shares of Dendreon fell after analysts from R.W. Baird cut their price estimates for the drugmaker to $14 from $20. According to analyst notes, cited by Forbes, oncologists said they haven’t been reimbursed yet for the company’s prostate cancer drug Provenge because of Medicare and regional carrier issues. And R.W. Baird cited a survey, performed by ICI OncoReports, that found some doctors are using J&J’s new drug Zytiga in patients who might otherwise have qualified for Provenge. It was the latest sign that demand for the prostate cancer vaccine might continue to slacken since Dendreon withdrew its revenue forecast for Provenge earlier this year.
