The US Food and Drug Administration (FDA) has granted a priority review for Bayer and Johnson & Johnson's Xarelto as a treatment for deep vein thrombosis (DVT) or pulmonary embolism (PE), which could open up a lucrative new market for the oral anticoagulant.
The new indication for Xarelto (rivaroxaban) also covers the prevention of recurrent DVT and PE, with the two conditions affecting an estimated 300,000 to 1,600,000 patients each year in the US, killing between 60,000 and 100,000 people.
Xarelto is currently licensed in the US to reduce the risk of stroke and blood clots in people with atrial fibrillation and to reduce the risk of blood clots in people who have just had knee or hip replacement surgery.
Bayer achieved €86m ($110m) in Xarelto sales in 2011, with approval in DVT and PE expected to open a new market for the drug worth around $1bn. Bayer has previously said it expects the drug to achieve more than €2bn ($2.46bn) a year at peak.
The new submissions are supported by data from the 10,000-patient EINSTEIN programme, which demonstrated the oral single-dose drug was as effective as Sanofi's Lovenox (enoxaparin) plus a vitamin K antagonist, but offered a simpler dosing regimen and a superior safety profile with regards to incidents of major bleeding.
Xarelto has already been approved in Europe for the treatment of DVT and the prevention of recurrent DVT and PE following an acute DVT in adults, getting the green light for this indication at the end of last year.
Approval for DVT and PE could give Bayer and J&J an edge over rival Boehringer Ingelheim, whose own oral anticoagulant Pradaxa (dabigatran etexilate) is available in both the US and Europe for the prevention of stroke in patients with AF, as well as to prevent blood clots following hip and knee replacement surgery in Europe.
Both Pradaxa and Xarelto are part of a new generation of oral anticoagulants that are set to replace warfarin, which can be cumbersome to administer. Xarelto is a Factor Xa inhibitor while Pradaxa is a direct thrombin inhibitor.
Meanwhile, Bayer and J&J said they have withdrawn an application to market Xarelto for reducing the risk of stent thrombosis in patients with acute coronary syndrome (ACS), after a complete response letter from the FDA raised a number of issues with a separate dossier filed for secondary prevention of cardiovascular events in ACS.
The two companies have said they are working to address the FDA's concern and plan to resubmit the application for Xarelto in stent thrombosis "at the same time as the reply to the complete response letter in ACS".