The US Food and Drug Administration (FDA) has requested more data from Bristol-Myers Squibb (BMS) and Pfizer before it can approve Eliquis as a preventative treatment for stroke and systemic embolism in patients with non-valvular atrial fibrillation.
The agency issued a complete response letter to the two pharma companies requesting additional information on data management and verification in the phase III ARISTOTLE trial, which was used to support the drug's application for what would be its launch onto the US market.
The request the second stumbling block this year for Pfizer and BMS, after the FDA said in March 2012 it had to extend the deadline for review by three months because it needed more time to look at a "major amendment" to the dossier.
Eliquis (apixaban) had initially been given a priority review status by the FDA, which the agency only offers to drugs that offer major advances in treatment or provide a treatment where no adequate therapy exists, with an initial deadline of March 28, 2012, to complete the review process.
It's unclear how long the latest FDA request will delay a final decision by, although BMS and Pfizer said no new studies would need to be completed.
“There is a significant unmet need to reduce the risk of stroke in patients with atrial fibrillation,” said Elliott Sigal, executive VP and chief scientific officer, BMS.
“We believe that the two large trials called ARISTOTLE and AVERROES have established the therapeutic profile for Eliquis and demonstrated a meaningful advance over the standard of care.”
Other anticoagulants currently available in the US for the prevention of stroke and systemic embolism in patients with nonvalvular atrial fibrillation include Johnson & Johnson and Bayer's Xarelto (rivaroxaban) and Boehringer Ingelheim's Pradaxa (dabigatran etexilate mesylate).
These rival drugs are also approved for a variety of other indications in both the EU and US, while Eliquis is so far only approved for the prevention of venous thromboembolic events (VTE) in adult patients who have undergone elective hip or knee replacement surgery.
BMS and Pfizer said they would continue to press on with ongoing applications for Eliquis' use in the prevention of stroke in patients with atrial fibrillation in markets outside of the US, including the EU and Japan.