Healthcare giant Johnson & Johnson’s (NYSE:JNJ) division Janssen Research & Development announced late Thursday that the U.S. Food and Drug Administration (FDA) has declined to approve a new use of the company’s blood clot reducer Xarelto, also known as rivaroxaban.
The FDA's Cardiovascular and Renal Drugs Advisory Committee narrowly voted against recommending approval of Xarelto for use in reducing the risk of secondary cardiovascular events in patients with acute coronary syndrome (ACS).
Xarelto is an anticoagulant that works by blocking the blood clotting Factor Xa, thereby reducing the tendency to form clots.
The drug is approved for three clinical uses in the United States, including reducing the risk of blood clots in the legs and lungs in knee replacement and hip replacement surgery patients, and to reduce the risk of both hemorrhagic and thrombotic strokes in people with atrial fibrillation that is not caused by a heart valve problem.
The FDA issued a complete response letter regarding the new drug application, and Janssen said that it is evaluating the FDA’s response and will respond to the agency’s questions.
"We are confident in the robust study results of the ATLAS ACS 2 TIMI 51 trial and the positive benefit-risk profile of rivaroxaban in patients with ACS," said Janssen’s vice president and cardiovascular franchise medical leader, Dr. Paul Burton.
"We will continue to work with the FDA to fully address their questions as quickly as possible."
ACS is a complication of coronary heart disease that happens when blood clots block a coronary artery, reducing blood supply to the heart. This blockage could cause a heart attack, or unstable angina that signifies a heart attack may be on its way.
It is the leading cause of death in the United States.
Janssen submitted the supplemental new drug application for Xarelto last December, and received a priority review designation from the FDA in February.
The application included results from its phase 3 ATLAS ACS 2 TIMI 51 clinical trial, which were presented at the American Heart Association annual Scientific Sessions in November 2011.
Janssen is jointly developing Xarelto with Bayer Healthcare. The drug's U.S. marketing rights are held by Janssen Pharmaceuticals.
To date, more than 1.5 million patients have received Xarelto across the globe, with nearly 350,000 prescriptions written for the drug in the United States alone.