FDA Panel Again Rejects J&J's Bid To Expand Anticoagulant Xarelto Use
The U.S. Food and Drug Administration (FDA) panel has again rejected pharmaceutical giant Johnson & Johnson’s bid to expand use of its blood thinner drug Xarelto (rivaroxaban). The FDA panel previously rejected the company’s application for approval, citing lack of substantial information from Johnson & Johnson’s studies. Johnson & Johnson first applied for wider Xarelto use approval in late 2011 but was subsequently rejected in January, May, and June in 2012.
Xarelto is used to prevent and treat pulmonary embolism and deep vein thrombosis. At present, the drug is marketed to patients with irregular heartbeats, those at risk from leg blood clot formation, and those undergoing hip/knee replacements. The company reported sales of more than $245 million in its last fiscal quarter for Xarelto.
Johnson & Johnson submitted clinical trial study data suggesting proof of Xarelto’s effectiveness in reducing risk of additional heart problems in patients who have recent history of a heart attack. The company sought approval of Xarelto use for patients with acute coronary syndrome (ACS). However, the FDA panel inquired about whether Xarelto’s benefits counterbalance its associated heightened risk of bleeding in patients. The panel also expressed concern regarding the large number of patient drop outs in the company studies, in addition to the lack of sufficient information.
Johnson & Johnson’s proposal included a warning regarding Xarelto’s combined use with Eli Lilly & Co’s Effient (prasugrel) and AstraZeneca’s Brilinta (ticareglor) due to risk of bleeding.
Janssen R&D Vice President of Clinical Development Dr. Paul Burton said Johnson & Johnson believes that, in conjunction with standard treatments, Xarelto “delivers a strong incremental benefit by significantly reducing the risk of cardiovascular events, including death, at a time when patients are at the highest risk.” Janssen is a subsidiary unit of Johnson & Johnson.
The company is not required to follow the FDA panel’s review and recommendation.
Source:
http://www.reuters.com/article/2014/01/14/us-jj-xarelto-fda-idUSBREA0D0UV20140114
http://finance.yahoo.com/news/fda-panel-again-rejects-wider-212127746.html