US regulator had asked for more data from Pfizer and BMS
The US Food and Drug Administration (FDA) has accepted Pfizer and Bristol-Myers Squibb's re-filed marketing application for its new anticoagulant Eliquis as a preventative treatment for stroke and systemic embolism in patients with non-valvular atrial fibrillation (AF).
The agency has set a new date of March 13, 2013 to review the dossier, about a year later than it was originally supposed to deliver a verdict on Eliquis (apixaban) under its priority review track.
In June, the FDA asked for more data on data management and verification in Pfizer and BMS' ARISTOTLE trial, after delaying its review for three months in March because of amendments filed by the two companies.
"The FDA has deemed the resubmission a complete response" to its request for more data, said the firms in a statement, indicating that the registration programme for Eliquis is now back on track.
The filing draws on data from the ARISTOTLE and AVERROES studies, which together enrolled 24,000 patients with non-valvular AF and found that the new drug was more effective than warfarin and aspirin in preventing stroke and systemic embolism.
The drug has already been recommended for approval for this indication in Europe, where it was registered in May 2011 for the prevention of venous thromboembolic events (VTE) in adult patients who have undergone elective hip or knee replacement surgery.
Other anticoagulants currently available in the US for the prevention of stroke and systemic embolism in patients with non-valvular atrial fibrillation include Johnson & Johnson and Bayer’s Xarelto (rivaroxaban) and Boehringer Ingelheim’s Pradaxa (dabigatran etexilate mesylate).
Eliquis is considered a blockbuster-in-waiting for BMS and Pfizer as the AF market is estimated at around $9bn a year and there is still significant unmet medical need in the category, with analysts predicting the drug could garner $3.5bn-$4bn a year at peak.