J&J, Bayer try to answer FDA concerns on Xarelto

Bayer and Johnson & Johnson are making another run at getting their anti-clotting drug Xarelto approved for ACS patients, a market that analysts say would take it into blockbuster territory.

Johnson & Johnson ($JNJ) has responded to FDA concerns about a clinical study and bleeding risks from Xarelto, Bayer announced today. The agency in June turned down the application to get the drug approved for the prevention of heart attacks or strokes in patients who suffer acute coronary syndrome (ACS). Bayer also said it is asking the FDA to approve the drug for use with standard anti-platelet therapy to reduce the risk of stent thrombosis in patients with ACS, it says in a release.

It was not a big surprise when the FDA denied Xarelto's use for ACS, a use that would have significantly enhanced the drug's financial value. The negative response was put into the inevitable category in May when an FDA advisory committee recommended against approval because of missing data after nearly 1,300 patients dropped out early of a 15,526-subject, final-phase study and withdrew consent for access to their health information. There are also concerns about bleeding risks for the class of drugs that are an alternative to warfarin.

Sold by Johnson & Johnson in the U.S., Xarelto is now approved to prevent strokes in patients with atrial fibrillation and to reduce the risk of blood clots in certain surgery patients, a market that in addition to the workhorse warfarin, includes one of the new-generation warfarin alternatives, Boehringer Ingelheim's Pradaxa. Others are in line for approval, including Pfizer ($PFE) and Bristol-Myers Squibb's ($BMY) entrant Eliquis. The FDA in June also asked Pfizer and BMS to provide more data on Eliquis.

For ACS patients, Xarelto would have been the sole warfarin alternative approved in a market that some analysts peg at $1 billion. It would compete with AstraZeneca's ($AZN) Brilinta and Eli Lilly's ($LLY) Effient, and market-watchers think it could dominate.

J&J owns U.S. rights to the medicine while Bayer sells the drug in Europe.

- here's the press release
- and here's a Reuters story

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