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FDA Rejects Expanded Indications for Anticoagulant Drug Xarelto (Rivaroxiban)

Agency advisors questioned clinical trial data (February 14)

The FDA has issued complete response letters (CRLs) regarding supplemental new drug applications (sNDAs) for the use of Xarelto (rivaroxaban, Janssen/Bayer HealthCare), an oral anticoagulant, to reduce the risk of secondary cardiovascular events — defined as heart attack, stroke, or death — in patients with acute coronary syndrome (ACS) and to reduce the risk of stent thrombosis in the same population, in combination with standard antiplatelet therapy.

Both sNDAs were based on results from the 15,526-patient pivotal phase III ATLAS ACS 2 TIMI 51 (Anti-Xa Therapy to Lower cardiovascular events in Addition to aspirin with/without thienopyridine therapy in Subjects with Acute Coronary Syndrome) trial of rivaroxaban, which was published in the New England Journal of Medicine in November 2011.

An FDA advisory panel concluded in January that clinical data from a single pivotal trial were not strong enough to justify approval to market Xarelto to prevent further heart problems, especially since some data were missing.

Rivaroxaban works by blocking a blood-clotting factor (Factor Xa). The drug is currently approved for six indications:

  • To reduce the risk of strokes and blood clots in patients with atrial fibrillation not caused by a heart valve problem
  • To treat patients with deep vein thrombosis (DVT)
  • To treat patients with pulmonary embolism (PE)
  • To reduce the risk of recurrence of DVT or PE following an initial 6-month treatment for acute venous thromboembolism
  • To reduce the risk of blood clots in the legs and lungs of patients who have just had knee-replacement surgery
  • To reduce the risk of blood clots in the legs and lungs of patients who have just had hip-replacement surgery

Sources: Johnson & Johnson; February 14, 2014; and Reuters; February 14, 2014.

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