Pfizer ($PFE) and its partner Bristol-Myers Squibb ($BMY) will have to wait an extra few months before hearing whether the FDA will sign off on marketing approval for apixaban, their blockbuster anti-clotting hopeful.
In a brief release, the companies said they had submitted additional information for their NDA, which qualified as a "major amendment" that required added review time for the drug, dubbed Eliquis for commercial purposes. The new PDUFA date is now June 28 and the developers added that there are currently no plans for an advisory panel review.
The FDA had offered a priority review for apixaban in November as the partners hustled to reach the $9 billion market for anti-clotting drugs. If an approval comes through this summer, it will be a year after the EMA formally sanctioned the therapy. The delay also gives Boehringer Ingelheim and Bayer/J&J ($JNJ) more time to penetrate the market with their new therapies.
Analysts have given apixaban a solid shot at an approval, setting up a major showdown on the market with the arrival of a new treatment that is widely viewed as a major advance on warfarin, the old standard. Tim Anderson at Bernstein, who expects a panel review for apixaban, had estimated that the treatment could grab $395 million in sales this year and $3.7 billion by 2020. That initial timeline is likely to change a bit. Leerink Swann's Seamus Fernandez has estimated peak Eliquis sales at $4.2 billion in 2017.
For BMS, an approval would continue a regulatory streak that has included several key approvals. But for Pfizer, which has had a rocky road in the clinic, a megablockbuster OK would help redeem the company's tarnished reputation in R&D.
- here's the press release
- here's the AP report
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