New anticoagulant in the hot seat
However, despite FDA's concerns with the ROCKET-AF trial, numerous studies, including one presented at last week’s European Society of Cardiology meeting in Paris, have reported that apixaban may be superior to warfarin in terms of preventing stroke or systemic embolism in atrial fibrillation (AF) patients.
ROCKET AF, published in the New England Journal of Medicine last month, reported similar results, highlighting that rivaroxaban can prevent stroke in AF patients. However, the FDA disagrees. In fact, briefing documents by the agency argue against the drug's new drug application, despite positive results.
The FDA said that ROCKET AF data are not robust enough and did not demonstrate that rivaroxaban is as effective in preventing strokes and systemic emboli as warfarin. While rivaroxaban is approved in the European Union to prevent deep vein thrombosis in patients undergoing knee or hip surgery, FDA said it has concerns with the proposed labeling for the drug to be used in AF patients.
The agency said that it will argue against the drug and study data in today's meeting. But will the reasonably positive data shown in previous studies portray more positives than negatives or will rivaroxaban, a drug that once held promise, be placed last in the race to find a safe and effective anticoagulant?
Stay tuned for the results of the committee meeting, which Cardiovascular Business will release later today.
Cardiovascular Business, senior writer