J&J's Janssen Research & Development announced that the FDA has granted Priority Review to a supplemental New Drug Application for Xarelto to include a 10 mg once-daily dose.
Approval of 10 mg dose would provide physicians another option to customize patient treatment plans for reducing the risk of VTE (Venous thromboembolism) after at least six months of standard anticoagulant therapy.
The application is based on data from EINSTEIN CHOICE, which found a non-vitamin K antagonist oral anticoagulant (NOAC), specifically two doses of Xarelto (10 mg and 20 mg), to be superior to aspirin in reducing the risk of recurrent VTE, with comparable rates of major bleeding.
J&J is currently facing an estimated 18,600 lawsuits in federal and state courts addressing product liability issues over Xarelto's bleeding risks.
Read the press release