Bayer submits new Xarelto indications for European approval
pharmafile | January 6, 2011 | News story | Sales and Marketing | Bayer, DVT, Xarelto, atrial fibrillation, deep vein thrombosis, pulmonary embolism, rivaroxaban, stroke prevention
Bayer is seeking European regulatory approval for a batch of new indications for its oral anticoagulant Xarelto.
The company is looking to expand the drug’s licenced indications to include stroke prevention in patients with atrial fibrillation, the treatment of deep vein thrombosis (DVT) and the prevention of recurrent DVT and pulmonary embolism.
Xarelto (rivaroxaban) is a factor Xa inhibitor that was first approved in 2008 with an indication to prevent venous blood clots in patients undergoing elective hip or knee replacement surgery.
Its latest licence applications are based on recent phase III trials that include Bayer’s ROCKET trial and two EINSTEIN studies looking at the separate effects of Xarelto on atrial fibrillation, DVT and pulmonary embolism.
Bayer is co-developing Xarelto with Johnson & Johnson in the US and said J&J had filed its complete response with the FDA following the US regulator’s safety concerns with the drug.
If approved by the FDA, the drug will be commercialised by J&J’s Ortho-McNeil division and Bayer will provide sales force support for certain hospital accounts.
Xarelto is part of a new class of anticoagulants looking to replace the standard treatment warfarin and was awarded the prestigious Prix Galien Award in October for the most innovative new medicine.
Warfarin, first designed for use as rat poison, has been used as an oral anti-clotting agent for both post-surgery prevention of VTE and atrial fibrillation prevention for over 60 years, but it interacts with many common medications and requires close GP monitoring due to the risk of excessive bleeding.
Xarelto has been in competition with Pfizer/BMS’ apixaban and Boehringer Ingelheim’s Pradaxa to replace warfarin.
Pradaxa stole a march over its rivals in October when it received approval from the FDA for stroke risk reduction in patients with non-valvular atrial fibrillation.
Ben Adams
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