PharmaLytica 2021 Hyderabad review.

Janssen seeks USFDA approval for new indication to expand use of rivaroxaban in PAD patients

October 28, 2020

Bayer’s development partner, Janssen Research & Development, LLC, has submitted a supplemental New Drug Application (sNDA) to the US Food and Drug Administration (FDA) for a new indication to expand the use of Xarelto (rivaroxaban) in people with peripheral artery disease (PAD) to include those after recent lower-extremity revascularization due to symptomatic PAD.

They showed that Xarelto vascular dose (2.5 mg twice daily) plus aspirin (100 mg once daily) was superior to aspirin alone in reducing the primary efficacy endpoint; a composite of acute limb ischemia, major amputation of a vascular etiology, heart attack, ischemic stroke or cardiovascular death, with similar rates of Thrombolysis in Myocardial Infarction (TIMI) major bleeding.

Two major phase III trials - VOYAGER PAD and COMPASS - have now evaluated the use of dual antithrombotic pathway inhibition with Xarelto in combination with aspirin in more than 14,000 patients with PAD. Xarelto, in combination with aspirin, was approved by the US FDA in 2018 to reduce the risk of major cardiovascular (CV) events in patients with chronic PAD and coronary artery disease (CAD). It is the only direct oral anticoagulant (DOAC) approved for use in these patients.

The VOYAGER PAD trial is the first to demonstrate the benefits of dual pathway inhibition in patients with symptomatic PAD post revascularization, for whom there are currently limited treatment options and no Class I Guideline recommended treatment.

“By demonstrating the efficacy of dual pathway inhibition in patients with PAD who have recently undergone a revascularization procedure, the VOYAGER PAD study results reinforce the benefits of Xarelto in patients with PAD,” said Dr Joerg Moeller, member of the Executive Committee at Bayer AG’s Pharmaceuticals Division and Head of Research and Development.

PAD is caused by atherosclerosis, a chronic progressive disease, which is characterized by a build-up of plaque in the arteries limiting blood flow to the limbs. It is a serious underlying health crisis that impacts an estimated 20 million Americans with only 8.5 million diagnosed. PAD increases the risk for major CV events and is the leading cause of amputation which can double a patient’s risk of death.

In Europe, Bayer had submitted a variation to include the VOYAGER PAD data in the label of Xarelto in August 2020. The treatment of patients with symptomatic PAD at high risk for ischaemic events is already approved for Xarelto when co-administered with aspirin. The VOYAGER PAD study proves the benefits of Xarelto in patients with symptomatic PAD after lower-extremity revascularization.

The phase III VOYAGER PAD study included 6,564 patients from 542 sites across 34 countries worldwide. In the study, patients were randomized to receive either Xarelto 2.5 mg twice daily plus aspirin 100 mg once daily or aspirin 100 mg once daily alone. The primary efficacy endpoint was a composite of acute limb ischemia, major amputation of a vascular etiology, heart attack (myocardial infarction, MI), ischemic stroke or cardiovascular death. The primary safety outcome was major bleeding according to the Thrombolysis in Myocardial Infarction (TIMI) classification. Xarelto is approved in more than 130 countries, whilst the approved labeling, including the number of indications may differ from country to country.

Rivaroxaban was discovered by Bayer, and is being jointly developed with Janssen Research & Development, LLC. Xarelto is marketed outside the US by Bayer and in the US by Janssen Pharmaceuticals, Inc. (Janssen Research & Development, LLC and Janssen Pharmaceuticals, Inc. are part of the Janssen Pharmaceutical Companies of Johnson & Johnson).


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