September 23rd, 2011
Rivaroxaban (Xarelto) Gets Positive Recommendation for AF and DVT in Europe
The European Committee for Medicinal Products for Human Use (CHMP) has recommended that rivaroxaban (Xarelto) be approved for the prevention of stroke and systemic embolism in AF, according to Bayer HealthCare. CHMP has also recommended the drug’s approval for the treatment of DVT and for the prevention of recurrent DVT and PE following acute DVT. Bayer is developing the drug in conjunction with Johnson & Johnson.
Rivaroxaban is already approved in Europe for the prevention of VTE following hip- or knee-replacement surgery. Bayer said that approval for the new indications would make rivaroxaban the first new oral anticoagulant in the EU with all three indications.
The AF recommendation was based on the ROCKET AF study, which was the subject of intense scrutiny and controversy a few weeks ago at the FDA advisory panel. The DVT recommendation is based on the EINSTEIN-DVT study.