Vorapaxar, rivaroxaban up for review

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The FDA’s Cardiovascular and Renal Drugs Advisory Committee faces a full docket of applications for treatments for acute coronary syndrome and other diseases in January and February.

The panel will discuss a new drug application (NDA) Jan 15 for vorapaxar sulfate (Zontivity, Merck) to reduce atherothrombotic events in patients with a history of MIs. Vorapaxar plus aspirin has been shown to reduce the risk of cardiovascular events in atherosclerosis patients but it may carry bleeding risks.

Panelists also will review of a supplemental NDA Jan. 16 for rivaroxaban, a factor Xa inhibitor. Janssen Pharmaceuticals is seeking approval for rivaroxaban (Xarelto) to reduce the risk of thrombotic cardiovascular events in patients in the first 90 days after experiencing an acute coronary syndrome (ACS).

The FDA approved rivaroxaban in July 2011 to reduce the risk of deep vein thrombosis (DVT) and pulmonary embolism (PE) after knee or hip replacement surgery, and in November 2011 it was approved to reduce the risk of stroke in people who have nonvalvular atrial fibrillation. The agency expanded approval to include treating DVT or PE and to reduce the risk of recurrent DVT and PE following initial treatment.

But the drug has faced headwinds in the U.S. for use in ACS patients.

The panel will reconvene Feb. 12 to review an NDA for the antiplatelet drug cangrelor (The Medicines Company) to reduce the risk of stent thrombosis and other thrombotic cardiovascular events in patients with coronary artery disease undergoing PCI. The Medicines Company proposes that cangrelor, an intravenous adenosine diphosphate–receptor antagonist, be prescribed to maintain P2Y12 inhibition in at-risk patients when oral P2Y12 therapy is interrupted due to surgery.

In the CHAMPION-PHOENIX trial, cangrelor significantly reduced the rate of ischemic events, including stent thrombosis, during PCI, with no significant increase in severe bleeding.

The panel also will discuss a license application for serelaxin injection (Novartis) to improve the symptoms of acute heart failure on Feb. 13.