Bayer's oral blood thinner Xarelto has been submitted in the US for additional marketing authorisation, asking approval for an indication that could add substantial ballast to the drug's sales.
The group said its development partner Janssen Research and Development has handed in a supplemental New Drug Application to the US Food and Drug Administration seeking the all clear to market the drug for the treatment of patients with deep vein thrombosis (DVT) or pulmonary embolism (PE) and the prevention of recurrent venous thromboembolism (VTE).
The submissions are based on data from the global EINSTEIN programme involving almost 10,000 patients, which assessed the use of Xarelto (rivaroxaban) in patients with the above conditions.
Data from the EINSTEIN-PE arm of the programme showed that Xarelto was as safe and effective as the current dual therapy approach of subcutaneous enoxaparin (Sanofi's Lovenox) followed by warfarin in treating patients with PE or preventing a secondary VTE.
And crucially, while Xarelto demonstrated a similar overall bleeding rate compared with the current standard of care, it was linked with significantly lower rates of major bleeding which, combined with its one pill regimen, could help give it a competitive edge.
In December last year, European regulators approved the drug's use for the treatment of DVT and the prevention of recurrent DVT and PE following an acute DVT, and just a few weeks ago an additional marketing application was made to the EMA to expand Xarelto's scope to treating PE and preventing recurrent DVT and PE.
Analysts believe that if the applications are successful, an indication in PE could swell Xarelto's sales by as much as $600 million to $1 billion.