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Response letter for Bayer’s Xarelto®


Bayer HealthCare has announced that the US Food and Drug Administration (FDA) issued a second complete response letter regarding the supplemental New Drug Application (sNDA) for the oral anticoagulant Xarelto® (rivaroxaban) 2.5mg BID in combination with standard antiplatelet therapy for the reduction of cardiovascular events (cardiovascular death, myocardial infarction or stroke) in patients with Acute Coronary Syndrome (ACS).
Bayer is evaluating the complete response letter from the FDA together with its cooperation partner Janssen Research & Development, LLC, and will respond to the Agency’s questions.
“We remain confident in the safety and efficacy of rivaroxaban in this indication and will work closely with our development partner Janssen Research & Development, LLC, to address the questions from the FDA,” said Dr. Kemal Malik, Member of the Bayer HealthCare Executive Committee and Head of Global Development.
Xarelto® is approved for six clinical uses in the US:
  • to reduce the risk of blood clots in the legs and lungs of adults who have just had knee replacement surgery
  • to reduce the risk of blood clots in the legs and lungs of adults who have just had hip replacement surgery
  • to reduce the risk of both hemorrhagic and thrombotic strokes as well as other blood clots in adults with atrial fibrillation not caused by a heart valve problem
  • to treat adults with pulmonary embolism (PE)
  • to treat adults with deep vein thrombosis (DVT)
  • to reduce the risk of recurrence of DVT or PE following an initial six months of treatment for acute venous thromboembolism
The sNDA includes results from the pivotal, global Phase III ATLAS ACS 2-TIMI 51 study, which showed that rivaroxaban 2.5 mg dosed twice daily in addition to standard antiplatelet therapy (low-dose aspirin with or without a thienopyridine such as clopidogrel or ticlopidine) significantly reduced the composite primary efficacy endpoint of cardiovascular death, myocardial infarction or stroke in patients after a recent ACS compared to those receiving standard antiplatelet therapy alone.
Rates of TIMI (Thrombolysis In Myocardial Infarction) major bleeding events not associated with coronary artery bypass graft (CABG) surgery were low overall, but rivaroxaban was associated with higher rates of these bleeds compared with standard therapy alone. Importantly, these differences were not associated with an increase in the risk of fatal bleeding or fatal intracranial haemorrhage (ICH).

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