New studies planned to further expand indications for Xarelto

German pharma major Bayer (BAYN: DE) and partner Janssen Research & Development, a unit of US health care giant Johnson & Johnson (NYSE: JNJ), says they are expanding the global clinical development program for the oral Factor Xa inhibitor Xarelto (rivaroxaban) for the prevention of potentially deadly blood clots in patients at risk of arterial thromboembolism.

Three new studies will investigate the efficacy and safety of rivaroxaban in: patients who have suffered an embolic stroke of undetermined source (ESUS); patients with peripheral artery disease (PAD) undergoing peripheral artery interventions; and Patients who have had an acute coronary syndrome (ACS).

"Together with our partner Janssen, we are committed to further investigate the potential benefits of rivaroxaban in areas of significant unmet medical need," said Joerg Moeller, a member of the Bayer HealthCare executive committee and head of global development. "Rivaroxaban is already approved to prevent and treat more venous and arterial thromboembolic conditions than any other novel oral anticoagulant. However, areas of unmet medical need still exist where rivaroxaban could potentially benefit even more patients at risk of the serious and often life-threatening diseases caused by blood clots," Dr Moeller pointed out.

Sales forecasts

Xarelto generated sales of $1.7 billion in the 12 months through June 2014, with some analysts estimating annual sales could rise to more than $9.5 billion by 2020.

Xarelto has already been approved for five indications in seven distinct areas of use. Yet the global burden of thrombosis-related diseases remains significant in a number of areas of unmet medical need. While the ongoing program for rivaroxaban, including Phase III studies like COMPASS, COMMANDER-HF, MARINER, and EINSTEIN CHOICE, addresses some of these, the medical need in three additional areas is still high, the drugmaker noted.