(RxWiki News) United States Food and Drug Administration officials today delayed approval of Eliquis (apixaban) to prevent stroke or systemic embolism in patients with a common heart arrhythmia for the second time.
The investigational blood thinning drug is a joint venture for pharmaceutical companies Bristol-Myers Squibb and Pfizer.
"Talk to a cardiologist about the risks from taking blood thinners."
Though the medication was approved by the European Union last year for prevention of blood clots in adult patients undergoing elective hip or knee replacement surgery, it has not had the same success in gaining U.S. approval.
In February 2012, the FDA delayed taking an action on the drug for three months. Today's delay stems from an FDA request for additional data on randomized trials the companies already have completed.
The drug makers had requested approval of the medication based on data from the Aristotle and Averroes studies, which included more than 24,000 patients with atrial fibrillation.
Thousands more are expected to participate in phase three trials of Eliquis through an ongoing clinical development program.
During the completed trials researchers found that the experimental drug lowered the risk of stroke better than blood thinner Coumadin (warfarin) and also resulted in fewer bleeding episodes.
The drug was designed as an alternative to warfarin, the current treatment standard for preventing blood clots. Warfarin requires regular blood testing and can interact with certain foods and other medications.
Eliquis had been widely anticipated because the oral drug would be easier to take, and studies had suggested it was safer.
FDA officials did not request additional trials. Both companies are currently working with the FDA to supply the requested data.
“There is a significant unmet need to reduce the risk of stroke in patients with atrial fibrillation,” noted Elliott Sigal, MD, PhD, executive vice president and chief scientific officer of Bristol-Myers Squibb.
