J&J loses key FDA panel vote on Xarelto

Johnson & Johnson's campaign to gain a key new approval for Xarelto (rivaroxaban) ran into stiff headwinds on Wednesday when it lost a narrow vote among a small group of FDA advisers. The balloting turned against J&J ($JNJ) after 6 of 10 outside experts concluded that the risk of bleeding and doubts about its pivotal data prevented them from endorsing an approval for preventing heart attacks and strokes among patients with heart problems. Four panel members voted for approval and one abstained.

J&J offered data demonstrating that the drug reduced the risk of death or stroke among acute coronary syndrome patients by 15%. But a majority of the panel questioned a significant increase in bleeding risk and wondered whether missing data on about 1,000 of the patients alongside a high dropout rate skewed the results in J&J's favor.  

"Were there not questions about loss to follow-up and missing data, it would have been a yes," said Allan Coukell, a consumer rep on the panel, according to the Reuters report. The Cleveland Clinic's Steven Nissen says he wasn't convinced by the data, adding that he was looking for a more "robust" set of figures before he could assent. 

J&J developed Xarelto with Bayer with an eye to tackling a market of a million ACS cases a year in the U.S.

Boehringer Ingelheim's Pradaxa beat a pack of rivals to the heart market and Eliquis, a competing drug from Pfizer ($PFE) and Bristol-Myers Squibb ($BMY) is being considered at the FDA now. Regulators are slated to decide formally on Xarelto's fate before the end of June.

"We appreciate the thoroughness of the committee's review, and will ensure the questions raised today are addressed with the FDA," said Paul Burton, a vice president with Janssen Research & Development, in a statement. 

- read the press release
- here's the Reuters story
- get the report from The New York Times

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