Bristol-Myers Squibb and Pfizer will have to wait a bit longer before getting US approval for their anti-clotting drug Eliquis.
The US Food and Drug Administration has extended the action date by three months for the New Drug Application for Eliquis (apixaban) for the prevention of stroke and systemic embolism in patients with atrial fibrillation. The new Prescription Drug User Fee Act (PDUFA) goal date is now June 28.
The reason for the delay is that subsequent to the filing of the NDA, the companies submitted additional information about the Eliquis clinical program to the FDA, "which constitutes a major amendment to the application and will require additional time for review".
B-MS and Pfizer noted that they will continue to work closely with the agency, adding that "at this stage there are no plans for an FDA advisory committee meeting to review the NDA for Eliquis". Analysts are not particularly concerned about the action date being pushed back on the oral Factor Xa inhibitor which, if approved, will go up against Boehringer Ingelheim's Pradaxa (dabigatran) and Bayer/Johnson & Johnson's Xarelto (rivaroxaban).
Tim Anderson at Sanford Bernstein issued a research note saying that "a small delay in the approval of Eliquis would not be terribly material" to either B-MS or Pfizer.