ImageBayer.jpg” style=”padding: 10px” width=”250″ />

Bayer HealthCare has submitted its Xarelto (rivaroxaban) to the Japanese Ministry of Health, Labour and Welfare for marketing approval of the drug.

Xarelto is indicated for the treatment of patients with deep vein thrombosis and pulmonary embolism, as well as prevention of recurrent venous thromboembolism.

Go deeper with GlobalData

Data Insights

The gold standard of business intelligence.

Find out more

Related Company Profiles

View all

The company has submitted Xarelto for the Japanese approval based on results from three global clinical trials within the pivotal EINSTEIN Clinical Trial Programme.

The submission is also supported by the J-EINSTEIN studies (J-EINSTEIN DVT and J-EINSTEIN PE) that were run entirely in Japan.

The EINSTEIN DVT and EINSTEIN PE studies compared rivaroxaban alone with the dual-drug regimen of low molecular weight heparin (LMWH) and a vitamin K antagonist (VKA) in the treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE) respectively, and in the prevention of recurrent DVT and PE.

"Pooled data of more than 8,000 patients reaffirmed that the single-drug approach with Xarelto is effective in both the treatment and subsequent prevention of recurrent DVT and PE."

The EINSTEIN Extension study assessed rivaroxaban versus placebo for the long-term prevention of recurrent symptomatic DVT and PE in patients who previously completed six or 12 months of anticoagulation treatment with either VKA or rivaroxaban.

How well do you really know your competitors?

Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.

Company Profile – free sample

Thank you!

Your download email will arrive shortly

Not ready to buy yet? Download a free sample

We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form

By GlobalData
Visit our Privacy Policy for more information about our services, how we may use, process and share your personal data, including information of your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address.

Pooled data of more than 8,000 patients reaffirmed that the single-drug approach with Xarelto is effective in both the treatment and subsequent prevention of recurrent DVT and PE, with an overall safety profile comparable to the traditional dual-drug regimen.

Xarelto significantly reduced the rate of major bleeding events by 46%, including the risk of fatal bleeding, when compared with the traditional dual-drug approach of injectable LMWH followed by a VKA.

Rivaroxaban has shown an improved benefit-risk profile regardless of patient age, frailty, gender, weight or renal function.

Bayer discovered rivaroxaban and it is being jointly developed with Janssen Research & Development. Janssen Pharmaceuticals is marketing Xarelto in the US, while Bayer is marketing the drug outside the US.

Image: Bayer submits Xarelto for marketing approval from Japanese Ministry of Health, Labour and Welfare. Photo: courtesy of Bayer HealthCare AG.