Bayer, J&J's Xarelto again falls short in bid for ACS use

Persistence may be a virtue, but it doesn't always pay. Johnson & Johnson ($JNJ) and Bayer tried again to persuade FDA on a new use for Xarelto, in patients with acute coronary syndrome (ACS). But once again, the attempt failed.

It's a blow for Xarelto, which so far has racked up 6 indications in the U.S. One of those addresses a big market--patients with atrial fibrillation--but the ACS population could have been even bigger. Some 1.2 million ACS patients are hospitalized each year. J&J and Bayer jointly developed the drug, and J&J has U.S. marketing rights.

FDA turned away J&J's first request for the new indication last June, citing some missing data on 1,000 trial participants who had pulled out. The agency was also concerned about the drug's bleeding risks. Janssen, the J&J prescription-drug development unit, came back with additional data, but that wasn't enough to sway the FDA.

Xarelto is one of the new generation of drugs challenging the standard anticoagulant warfarin. It came to market second, on the heels of Boehringer Ingelheim's Pradaxa. It's the only one of the three that had generated strong enough data in ACS patients to warrant an application for the indication. Pfizer ($PFE) and Bristol-Myers Squibb's ($BMY) new entry, Eliquis--which arguably has the best data of the three, overall--failed in an ACS trial. Currently, the clot-fighting drugs FDA-approved for that use are AstraZeneca's ($AZN) Brilinta and Eli Lilly's ($LLY) Effient, along with the Sanofi ($SNY)/Bristol-Myers drug Plavix, which is now off-patent.

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