FDA News

FDA now permits lower-dose rivaroxaban in treatment of VTE

Jeffrey Weitz

Bayer and Janssen Research and Development announced FDA approval for a label update of rivaroxaban treatment for venous thromboembolism.

A 10-mg daily dose of rivaroxaban (Xarelto) is now permitted after at least 180 days following a VTE event in patients at continued risk for deep vein thrombosis or pulmonary embolism, according to press releases from both companies.

The approved prescribing information up to 180 days remains the same: rivaroxaban 15 mg twice daily for 21 days after a VTE event, and rivaroxaban 20 mg once daily from 22 days to 180 days after an event, according to the releases.

The approval of the 10-mg treatment was based on data from the EINSTEIN CHOICE study.

“Patients at risk for recurrent VTE can now receive the 10 mg once daily dose of rivaroxaban,” Jeffrey Weitz, MD, FRCP(C), FACP, professor of medicine and biochemistry at McMaster University Heart & Stroke Foundation and J.F. Mustard Chair in Cardiovascular Research, Canada Research Chair in Thrombosis and executive director of the Thrombosis & Atherosclerosis Research Institute, said in an interview with Cardiology Today. “The EINSTEIN CHOICE study shows that this dose is effective and safe for this indication.”

The updated label may provide physicians with an opportunity to strengthen VTE treatment after 180 days from no treatment or aspirin to 10 mg of rivaroxaban, the releases stated.

“Patients who have previously suffered a VTE are often at increased risk of experiencing another event if anticoagulant treatment is stopped," Joerg Moeller, MD, member of the executive committee of Bayer AG's pharmaceutical division and head of development, said in Bayer’s release. "The FDA approval of the 10-mg dose provides physicians with an additional therapeutic option enabling them to continue the extended treatment with the regimen that best suits the benefit-risk-assessment of the individual patient."

“Patients at high risk for recurrence were not included in the EINSTEIN CHOICE study. Such patients might include patients with VTE in the setting of active cancer or those with a severe thrombophilia such as antithrombin deficiency, deficiencies of protein C or S, or antiphospholipid syndrome,” Weitz said in an interview. “These patients likely require continued anticoagulation treatment and are probably best managed with the 20-mg once-daily dose of rivaroxaban until more data are available.”

In the Janssen release, Paul Burton, MD, PhD, FACC, vice president of medical affairs at Janssen, said that “we believe the availability of the 10-mg dose will change clinical practice and the management of VTE recurrence. The landmark EINSTEIN program results yet again demonstrate Xarelto is a safe and highly effective option, not only for the initial treatment of a VTE, but also for the continued prevention of a recurrent event.” – by Dave Quaile

Disclosures: Burton reports he is an employee of Janssen. Moeller reports he is an employee of Bayer. Weitz reports he is a consultant for and received honoraria from Bayer, Boehringer Ingelheim, Bristol-Myers Squibb, Ionis, Janssen, Merck, Novartis, Pfizer and Portola.

 

Jeffrey Weitz

Bayer and Janssen Research and Development announced FDA approval for a label update of rivaroxaban treatment for venous thromboembolism.

A 10-mg daily dose of rivaroxaban (Xarelto) is now permitted after at least 180 days following a VTE event in patients at continued risk for deep vein thrombosis or pulmonary embolism, according to press releases from both companies.

The approved prescribing information up to 180 days remains the same: rivaroxaban 15 mg twice daily for 21 days after a VTE event, and rivaroxaban 20 mg once daily from 22 days to 180 days after an event, according to the releases.

The approval of the 10-mg treatment was based on data from the EINSTEIN CHOICE study.

“Patients at risk for recurrent VTE can now receive the 10 mg once daily dose of rivaroxaban,” Jeffrey Weitz, MD, FRCP(C), FACP, professor of medicine and biochemistry at McMaster University Heart & Stroke Foundation and J.F. Mustard Chair in Cardiovascular Research, Canada Research Chair in Thrombosis and executive director of the Thrombosis & Atherosclerosis Research Institute, said in an interview with Cardiology Today. “The EINSTEIN CHOICE study shows that this dose is effective and safe for this indication.”

The updated label may provide physicians with an opportunity to strengthen VTE treatment after 180 days from no treatment or aspirin to 10 mg of rivaroxaban, the releases stated.

“Patients who have previously suffered a VTE are often at increased risk of experiencing another event if anticoagulant treatment is stopped," Joerg Moeller, MD, member of the executive committee of Bayer AG's pharmaceutical division and head of development, said in Bayer’s release. "The FDA approval of the 10-mg dose provides physicians with an additional therapeutic option enabling them to continue the extended treatment with the regimen that best suits the benefit-risk-assessment of the individual patient."

“Patients at high risk for recurrence were not included in the EINSTEIN CHOICE study. Such patients might include patients with VTE in the setting of active cancer or those with a severe thrombophilia such as antithrombin deficiency, deficiencies of protein C or S, or antiphospholipid syndrome,” Weitz said in an interview. “These patients likely require continued anticoagulation treatment and are probably best managed with the 20-mg once-daily dose of rivaroxaban until more data are available.”

In the Janssen release, Paul Burton, MD, PhD, FACC, vice president of medical affairs at Janssen, said that “we believe the availability of the 10-mg dose will change clinical practice and the management of VTE recurrence. The landmark EINSTEIN program results yet again demonstrate Xarelto is a safe and highly effective option, not only for the initial treatment of a VTE, but also for the continued prevention of a recurrent event.” – by Dave Quaile

Disclosures: Burton reports he is an employee of Janssen. Moeller reports he is an employee of Bayer. Weitz reports he is a consultant for and received honoraria from Bayer, Boehringer Ingelheim, Bristol-Myers Squibb, Ionis, Janssen, Merck, Novartis, Pfizer and Portola.