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European committee adopts positive opinion on rivaroxaban for ACS

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The Committee for Medicinal Products for Human Use has adopted a positive opinion for expanding the indication of rivaroxaban to include patients with ACS, according to a press release issued by the agency.

This news run counter to the decision of the FDA earlier this month to decline for a second time the request of the manufacturer (Janssen Pharmaceuticals) to expand use of rivaroxaban (Xarelto) to this patient population.

Specifically, the new indication endorsement is for a new strength (2.5 mg) and for the following indication:

“Xarelto, co-administered with acetylsalicylic acid (ASA) alone or with ASA plus clopidogrel or ticlopidine, is indicated for the prevention of atherothrombotic events in adult patients after an [ACS] with elevated cardiac biomarkers.”

Also, according to the release, “Detailed conditions for the use of this product will be described in the updated summary of product characteristics (SmPC), which will be published in the revised European public assessment report (EPAR), and will be available in all official European Union languages after the variation to the marketing authorization has been granted by the European Commission.”