FDA issues second complete response letter for Xarelto

FDA has issued a second complete response letter regarding a supplemental New Drug Application (sNDA) for rivaroxaban  (Xarelto, Janssen) for the reduction of the risk of cardiovascular events in patients with acute coronary syndrome (ACS). 

Janssen is evaluating the letter and will respond to the agency’s questions.

“The sNDA for Xarelto for the reduction of risk of cardiovascular events in patients with acute coronary syndrome provides another opportunity for this agent to provide its therapeutic benefit to another patient population,” said Formulary Advisor Abimbola Farinde, PharmD, MS, clinical staff pharmacist at Clear Lake Regional Medical Center, in Webster, Texas.

“Xarelto already has an approved indication for the reduction of blood clots and recurrence of DVT or PE in a variety of conditions, and this proposed new indication only serves to add to the growing list,” Dr Farinde said.

The sNDA included results from the 15,526-patient pivotal phase 3 ATLAS ACS 2 TIMI 51 trial (Anti-Xa Therapy to Lower cardiovascular events in Addition to aspirin with/without thienopyridine therapy in Subjects with Acute Coronary Syndrome), as well as data from the 3,491-patient phase 2 ATLAS ACS 2 TIMI 46 trial.

“While we saw an increase in major bleeding, there was no increase in fatal bleeding,” said Christopher Nessel, MD, vice president at Janssen, in a press release. “We will continue to work with the FDA to address their questions.”

ACS is a complication of coronary heart disease, which is the leading cause of death in the United States and 1 of the most prevalent non-communicable diseases in the world. ACS occurs when a blood clot blocks a coronary artery, reducing blood supply to the heart.

This disruption of blood flow can cause a heart attack, or unstable angina, a condition signifying that a heart attack may soon occur. Each year, an estimated 1.2 million patients in the United States are discharged from the hospital with a diagnosis of ACS.

Xarelto has the broadest indication profile of any of the newer oral anticoagulants in the US market today and is approved for 6 clinical uses in the United States.