Pradaxa, Xarelto gain reprieve as FDA delays Eliquis decision

Pfizer ($PFE) and Bristol-Myers Squibb ($BMY) will have to wait three more months for the FDA's latest word on Eliquis. The anticoagulant drug has some of the strongest data among a new cadre of warfarin alternatives--so strong, in fact, the FDA put it on its fast track. But the drug will arrive late to the party, after Boehringer Ingelheim's first-to-market Pradaxa, and Bayer and Johnson & Johnson's ($JNJ) entry, Xarelto.

The delay gives Boehringer and J&J three more months to cement their positions in the warfarin alternative market in the U.S. Both drugs are FDA-approved for stroke prevention in patients with an abnormal heart rhythm known as atrial fibrillation, while Xarelto also is approved to reduce clotting risk in certain surgery patients.

Pradaxa has been on the market months longer than Xarelto, and so far, the Boehringer drug is holding its own with the biggest share of the market. But recent reports of serious bleeding in some patients prompted European regulators and Boehringer to advise caution on its use in some patients. Meanwhile, as Xarelto awaited its approval for AF patients, an FDA advisory panel raised questions about the clinical data, suggesting the trial design might have made the drug appear comparatively more effective than it would be in practice.

In a joint release, Pfizer and BMS said they submitted additional information to the FDA that amounted to a major amendment to their application for approval. So far, the agency hasn't made plans for an advisory panel hearing on the drug, although analysts are speculating that a scheduled meeting in May might focus on Eliquis, and perhaps Xarelto's proposed new use in patients with acute coronary syndrome, Forbes reports.

One question, raised by Sanford Bernstein anaylst Tim Anderson, is whether news of bleeding in Pradaxa patients is triggering more caution at the FDA. "Our best guess remains that FDA may be seeking cover, given the safety experience following competing drug Pradaxa's approval in 2010," Anderson said (as quoted by Forbes). "Additionally, FDA may be seeking advice on things like product labeling and what claims would be allowed."

- see the release from Pfizer
- get more from Forbes
- read the PM Live story

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