Bayer has filed to expand the indications for its oralanticoagulant Xarelto in Europe beyond its current use in preventing venousthromboembolism in patients undergoing hip or knee replacement surgery.
Top of the list of the new indications is strokeprevention in patients with atrial fibrillation, which Bayer has said coulddrive sales for Xarelto (rivaroxaban) to the 2 billion-euro mark andbeyond.
The two other new indications are the treatment of deepvein thrombosis and prevention of recurrent DVT and pulmonary embolism, both ofwhich could also give Xarelto sales a healthy lift.
The stroke prevention filing comes on the back ofpositive results from the 14,000-patient ROCKET study, which were reported atthe American Heart Association conference last November and showed that Xareltowas superior to the gold standard warfarin, with less risk of bleeding, inprotecting against stroke among patients with AF.
Bayer is bullish on the prospects for Xarelto in the 10billion-euro stroke prevention market, despite the approval of BoehringerIngelheim's Pradaxa (dabigatran etexilate) for this indication in the USA lastyear, pointing out that Xarelto benefits from once-daily dosing whilst Pradaxais taken twice-daily.
There have also been concerns raised about the bleedingrate seen with Xarelto at the US Food and Drug Administration, which requestedmore information from Bayer's US marketing partner for the drug, Johnson &Johnson, last March.
J&J said it had filed a response to the FDA that ithopes will answer the agency's safety concerns in the prevention of venousthromboembolism in patients undergoing hip or knee replacement surgery."The submission includes specific informationrequested by the FDA," said the company in a statement, adding theresponse is based on data from the Phase III RECORD trial. Meanwhile, J&Jalso confirmed it has filed to market Xarelto for the stroke preventionindication in the USA.