Tuesday, September 27, 2011

FDA Advisory Committee Recommends Approval of Rivaroxaban for Stroke Prevention in Patients with Atrial Fibrillation

On September 8, 2011, an FDA advisory committee recommended approval of rivaroxaban (Xarelto – Janssen Pharmaceutical / Johnson & Johnson) for stroke prevention in patients with atrial fibrillation (Afib).  While this is good stroke prevention news for patients with Afib, it is important to note that, at this point, FDA has not approved rivaroxaban and it is not bound to follow the advisory committee’s recommendation. For more information, click here.
Until recently, warfarin has been the only oral blood thinner available for 60 years. National Blood Clot Alliance (NBCA) President, Randy Fenninger said that “we await to learn of FDA’s decision. The National Blood Clot Alliance, on behalf of its Afib constituents looks forward to other safe and effective blood thinners to prevent strokes as well as the prevention of DVT/PE in other patients at risk.”
Rivaroxaban was approved in July 2011 for patients with total hip or knee replacement to prevent DVT/PE.  Rivaroxaban is one of several new oral anticoagulants (blood thinners) developed in the last several years as an alternative to warfarin for the treatment of Afib. Dabigatran (Boehringer Ingelheim) is FDA approved and Apixaban (Bristol-Myers Squibb/Pfizer) study data will be submitted to FDA for review.
“We rely on FDA to make sure that any new drug is safe and effective for patient use,” said Jack Ansell, MD, Chair of NBCA’s Medical and Scientific Advisory Board.  Dr. Ansell added that “warfarin is often difficult for patients and doctors to manage, and other blood thinner options are needed for preventing stroke in Afib patients and for treating patients at risk for or with DVT/PE.”....