So much for a speedy review of Eliquis, the new anticoagulant from Bristol-Myers Squibb ($BMY) and Pfizer ($PFE). After putting the drug on its fast track in November, the FDA first put off its decision date by three months, and now has issued a complete response letter looking for more data-crunching (but no new studies). Best expectation for an approval? Next spring.
That may be a setback for Bristol-Myers and Pfizer, but for Eliquis' rivals, it's a breather. Boehringer Ingelheim's Pradaxa and Johnson & Johnson's ($JNJ) Xarelto now have the warfarin-alternatives field to themeslves for the near term. And given the data on Eliquis--which suggests it could beat both drugs on efficacy and safety--that reprieve must be a welcome one.
And all the more welcome because it's unexpected. "All of this (delay) is surprising given the widespread perception that Eliquis is a best-in-class product relative to already-approved novel oral anticoagulants Pradaxa and Xarelto," Sanford Bernstein analyst Tim Anderson said in a note to investors.
It's particularly helpful for Xarelto. The J&J drug, developed in partnership with Bayer, just lost out on a new indication in patients with acute coronary syndrome, which includes those who've had a heart attack or suffer from chest pain. That could have been a lucrative market, one that Pradaxa and Eliquis couldn't compete in directly, unlikely as they were to win a similar indication. So, the Eliquis delay gives J&J more time to grab market share in atrial fibrillation patients.
Approved in 2010, a year ahead of Xarelto, Pradaxa has the lead in those patients, at least for now. Reports of bleeding-related deaths among Pradaxa users, including one highly publicized case of a patient who died after striking her head in a fall, have some doctors wary of using the drug. Statistically, the numbers aren't out of the realm predicted by clinical trials, Boehringer maintains, and millions of patients have used Pradaxa. But unlike warfarin, the old standard, there's no quick antidote to Pradaxa, or for any of its new rivals, for that matter.
- see the release from Bristol-Myers and Pfizer
- check out the Reuters news