Reducing the Risk of Heart Disease
Rivaroxaban* is a promising experimental medicine that may soon become a new alternative to warfarin for reducing the risk of unwanted blood clots.
Johnson & Johnson Pharmaceutical Research & Development, LLC (J&JPRD) recently submitted a New Drug Application to the U.S. Food & Drug Administration (FDA) seeking approval to use rivaroxaban to prevent strokes in patients with the most common heart rhythm disorder—atrial fibrillation. Results from the ROCKET AF trial, comparing rivaroxaban to warfarin, a widely used but challenging-to-manage drug, were presented at the American Heart Association annual meeting.
The study’s outcome suggests that “rivaroxaban has the potential to protect the 2.3 million Americans with atrial fibrillation from stroke and its devastating complications,” according to Peter M. DiBattiste, M.D., Vice President of Cardiovascular Development, J&JPRD. ROCKET AF is the seventh successful Phase III trial in the ongoing rivaroxaban development program.
In 2011, J&JPRD also expects to learn from the FDA whether rivaroxaban will be approved for the prevention of blood clots following total knee or total hip replacement surgeries.
*Rivaroxaban is co-developed with Bayer HealthCare.
Targeting Diabetes
Worldwide, 300 million people live with diabetes—almost equal to the entire U.S. population.
“Diabetes is a far-reaching, complex disease,” says Martin Fitchet, M.D., Head of the Cardiovascular and Metabolism Therapeutic Area. “We are working to develop new treatment options that will not only help better manage the disease but have the potential to limit its progression.”
In 2010, a large clinical development program for canagliflozin* and new collaborations supported the Company’s commitment to build a portfolio of diabetes treatments.
Canagliflozin is an investigational oral, selective sodium-glucose transporter-2 (SGLT2) inhibitor being studied in patients for the treatment of type 2 diabetes. The Phase III clinical trial program involves more than 10,000 patients.
A new collaboration with Metabolex, Inc. focuses on discovering, developing and commercializing new treatment options for people with type 2 diabetes and obesity. An agreement was entered into with Diamyd Medical AB to support the development of pharmaceuticals targeting autoimmune diabetes and its complications, in particular the treatment and prevention of type 1 diabetes.