Johnson & Johnson Submits Supplemental Application for XARELTO to Reduce Cardiovascular Events in Patients with Acute Coronary Syndrome

Strategic Insights -

Johnson & Johnson's Janssen Research & Development, LLC (JRD) has submitted a supplemental New Drug Application (sNDA) to the FDA seeking approval for the use of XARELTO (rivaroxaban) to reduce the risk of thrombotic cardiovascular events in patients with Acute Coronary Syndrome (ACS). The sNDA is supported by data from the pivotal Phase 3 ATLAS ACS 2 TIMI 51 trial, which demonstrated the efficacy of XARELTO in reducing the risk of cardiovascular events in patients with ACS. ACS is a complication of coronary heart disease, which is the leading cause of death in the US and a prevalent non-communicable disease worldwide.

Key Takeaways:

  • Janssen Research & Development, LLC (JRD) has submitted a supplemental New Drug Application (sNDA) to the FDA for the use of XARELTO (rivaroxaban) to reduce the risk of thrombotic cardiovascular events in patients with Acute Coronary Syndrome (ACS).
  • The sNDA is supported by data from the pivotal Phase 3 ATLAS ACS 2 TIMI 51 trial, which was presented in November at the American Heart Association Scientific Sessions and published in the New England Journal of Medicine (10.1056/NEJMoa1112277).
  • ACS is a complication of coronary heart disease, which is the leading cause of death in the US and one of the most prevalent non-communicable diseases worldwide.
  • The ATLAS ACS 2 TIMI 51 trial demonstrated the efficacy of XARELTO in reducing the risk of cardiovascular events in patients with ACS.
  • An estimated 1.2 million patients in the US are discharged from the hospital each year with a primary or secondary diagnosis of ACS.

Statistics:

  • 1.2 million patients: estimated number of patients in the US discharged from the hospital each year with a primary or secondary diagnosis of ACS.
  • 10.1056/NEJMoa1112277: journal reference and DOAJ of the New England Journal of Medicine publication regarding the ATLAS ACS 2 TIMI 51 trial.
  • 10.1056/NEJMoa1112277: (http://www.nejm.org/doi/pdf/10.1056/NEJMoa1112277): link to the New England Journal of Medicine publication regarding the ATLAS ACS 2 TIMI 51 trial.

Sources:

  • Janssen Research & Development, LLC, "Janssen Submits Supplemental New Drug Application for XARELTO (rivaroxaban) to Reduce Risk of Thrombotic Cardiovascular Events in Patients with Acute Coronary Syndrome"
  • New England Journal of Medicine, "Anti-Xa Therapy to Lower cardiovascular events in Addition to aspirin with/without thienopyridine therapy in Subjects with Acute Coronary Syndrome" (10.1056/NEJMoa1112277)
  • American Heart Association, "American Heart Association Scientific Sessions" (no date)