Johnson & Johnson's anticoagulant Xarelto has been approved by the US Food and Drug Administration for preventing stroke in patients with a common type of abnormal heart rhythm, despite earlier concerns raised by the US regulator's reviewers.
Xarelto (rivaroxaban) has been licensed for stroke prevention in patients with non-valvular atrial fibrillation (AF), a condition which affects around two million people in the USA.
The oral factor Xa inhibitor was filed for the AF indication on the strength of the ROCKET-AF trial, which was published in the New England Journal of Medicine in August. The study showed Xarelto was equivalent to warfarin in terms of its safety and efficacy, whilst offering advantages in terms of once-daily fixed dosing and no need for routine blood monitoring.
The FDA reviewers had previously voiced concerns that patients had not been treated optimally with warfarin, which could render the comparison between the two drugs unsound, but an advisory panel convened in September voted 9-2 in favour of approving the drug for the new indication.
Analysts have predicted that the market for warfarin replacements could reach as much as $9bn a year, with Xarelto predicted to make up to $3bn at peak.
Outside the US, Xarelto was recommended for approval for stroke prevention in AF patients in Europe last month, with an European Medicines Agency (EMA) advisory committee also giving a green light for the drug in the treatment and prevention of deep vein thrombosis (DVT) and pulmonary embolism. EU approval is expected before the end of the year, and the drug has also been filed for the AF indication in other markets, notably Japan.
The new product will be marketed in the US by J&J unit Janssen Pharmaceuticals, while Bayer has marketing rights for Xarelto in all markets outside the US. Bayer said its US sales team will support Janssen, however, in detailing to "designated hospital accounts".
First introduced in the US earlier this year for the prevention of DVT in people undergoing knee or hip replacement surgery, Xarelto was only the second non-warfarin oral anticoagulant to reach the market after Boehringer Ingelheim's Pradaxa (dabigatran), which debuted in 2008 and was approved for stroke prevention in AF patients last year.
Another drug vying for a slice of the stroke prevention market will be Pfizer and Bristol-Myers Squibb's Eliquis (apixaban), which was launched earlier this year in its first markets for the prevention of venous thromboembolic events (VTE) in patients undergoing hip or knee replacement surgery. Phase III trials suggest that Eliquis is the first oral anticoagulant to reduce all-cause mortality in AF patients, leading some observers to suggest it could lead the market for warfarin replacements.
Meanwhile, the US approval in AF puts Xarelto on track to reach its heady sales projections, and Bayer has been ramping up manufacturing capacity in anticipation. The company has also announced a €44 million investment programme at its manufacturing facilities in Wuppertal, Germany, in order to boost production capacity for Xarelto as well as other products such as diabetes treatment Glucobay (acarbose).