FDA rejects blockbuster Eliquis bid, asks Pfizer, BMS for trial clarification

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Bristol-Myers Squibb ($BMY) and Pfizer ($PFE) have hit another costly snag in their quest to gain an FDA approval for Eliquis (apixaban), their blockbuster anti-clotting hopeful. Regulators handed the development partners a complete response letter for the drug, asking for some clarification on data management and verification from their Aristotle trial, but steering clear of a demand for a new trial.

The new roadblock comes after regulators delayed their decision on apixaban last March so regulators could spend some time pondering new data which had been submitted for the program. European regulators approved the treatment a year ago and this fresh holdup at the FDA is a solid win for Boehringer Ingelheim and Johnson & Johnson, which beat the competition to the marketplace and now have additional breathing space to grow their markets ahead of a new rival.

This is a crucial drug program for both BMS and Pfizer. BMS is building on an ambitious and largely successful "string of pearls" strategy, while Pfizer has made apixaban a prime example of its rededication to smart drug development after a lengthy string of embarrassing pratfalls in the clinic. They also stand to earn quite a bit of money from an approval for a market worth $9 billion a year.  

Bernstein's Tim Anderson estimated that the treatment could grab peak sales of $3.7 billion by 2020 while Leerink Swann's Seamus Fernandez has estimated peak Eliquis sales at $4.2 billion in 2017. But every time regulators delay their bid for an approval the timeline stretches out a little further. 

Analysts recognize that a delay is not good news for the company, but most appear to be standing by their belief that an approval is now just a matter of time.

"Although this is a material time delay, we don't see an impact to our conclusion that Eliquis will eventually dominate the blood thinner space," ISI's Mark Schoenebaum noted this morning. 

"There is a significant unmet need to reduce the risk of stroke in patients with atrial fibrillation," said Elliott Sigal, the CSO at Bristol-Myers Squibb. "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."

- here's the press release
- read the Bloomberg report

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