Rack up another set of new uses for Bayer's Xarelto. The anticoagulant won European approval to treat and prevent pulmonary embolism and to prevent deep vein thrombosis. It's the first warfarin-alternative drug to win these indications, giving it an edge over its rival Pradaxa.
The European clearance follows a similar expansion of Xarelto's market in the U.S., where it's marketed by Bayer's development partner Johnson & Johnson ($JNJ). Early this month, FDA approved Xarelto to treat PE and DVT, and to prevent a recurrence after initial treatment. Both the EMA and FDA have cleared the drug to prevent clots in certain surgery patients and to reduce the risk of stroke in patients with atrial fibrillation.
It's all part of Bayer's plan to pump Xarelto into a major blockbuster. In a recent R&D update, CEO Marijn Dekkers touted his estimates for Xarelto once again, saying Bayer could realize $2.5 billion in annual sales from the drug.
The company also announced plans for a major outcomes study, which will pair Xarelto with aspirin. The aim is to determine whether the regimen will prevent stroke, heart attack and death in patients with coronary and peripheral artery disease.
It hasn't been all smooth sailing for the drug, however. Earlier this year, the FDA dealt a big disappointment to J&J and Bayer's hopes; it declined to approve it to prevent heart attacks and other cardiovascular events in patients with acute coronary syndrome. J&J has submitted new information to the agency, expecting a response early next year.