News Feature | September 3, 2014

Bayer, Janssen To Investigate Xarelto In 3 New Trials

By Estel Grace Masangkay

Bayer HealthCare announced that it is expanding its global clinical development program for Xarelto (rivaroxaban) with three new trials to be conducted jointly with its partner, Janssen R&D.

Xarelto is an oral Factor Xa inhibitor and anticoagulant developed for the treatment of serious and potentially life-threatening conditions. The drug is approved in five indications across seven areas of use. These include the prevention of stroke and systemic embolism in adults with non-valvular atrial fibrillation (AF) and reduction of recurring blood clots. Xarelto is authorized in all indications in more than 125 countries around the world.

The partners said that the drug will be investigated in the following indications:

  • Patients with embolic stroke of undetermined source (ESUS) – ESUS is responsible for around 25 percent of ischaemic strokes. The Phase III NAVIGATE ESUS will enroll around 7,000 patients across over 25 countries.
  • Patients with peripheral artery disease (PAD) – PAD progressively reduces the blood flow to the heart and limbs, putting patients at a higher risk of stroke, heart attack, and limb amputations. The condition affects an estimated 202 million people around the world. The VOYAGER PAD Phase III trial will involve over 5,000 patients in more than 20 countries.
  • Patients with acute coronary syndrome (ACS) – building on the results of the ATLAS ACS 2-TIMI 51 trial in which rivaroxaban as part of a combo therapy reduced cardiovascular death, stroke, heart attack, and stent thrombosis, the GEMINI ACS 1 Phase II study will investigate rivaroxaban for long-term prevention in ACS patients. The Phase II trial will enroll 2,000 to 3,000 patients in over 10 countries. If successful, Bayer will follow up the study with a confirmatory global Phase III trial.

Dr. Joerg Moeller, member of the Bayer HealthCare Executive Committee and Head of Global Development, said, “Together with our partner Janssen, we are committed to further investigate the potential benefits of rivaroxaban in areas of significant unmet medical need. 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.”