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FDA advisory panel turns down Xarelto for ACS

Contradicts previous support for drug from FDA reviewer

A US Food and Drug Administration (FDA) advisory committee voted against expanding the use of Bayer and Johnson & Johnson's Xarelto in patients with acute coronary syndrome (ACS) yesterday in a major disappointment for the two companies.

The panel voted by 6 to 4, with one abstention, against the use of Xarelto (rivaroxaban) in combination with standard antiplatelet therapy to reduce the risk of secondary cardiovascular events in patients with ACS, despite support for the new indication from the FDA's reviewer.

Bayer and J&J were hindered by missing data in the marketing application for Xarelto, which had been highlighted in the FDA's review document published ahead of the meeting. The document referred to "substantial missing data" relating to patient follow-up and other issues.

The discussion during the panel meeting centred on the follow-up data, with some panellists expressing concern that incomplete records were available for around 12 per cent of the patient population enrolled in the ATLAS ACS 2 TIMI 51 study supporting the marketing application.

There were also some issues raised about the bleeding risks with the regimen when used alongside standard antiplatelet therapy with aspirin and clopidogrel.

"We will ensure that the questions raised today are addressed so the FDA may finalise their review," said Dr Kemal Malik, Bayer's head of global development. The agency is due to deliver verdict on the application in June.

Xarelto is already approved in the US to reduce the risk of blood clots in the legs and lungs of people who have just had knee or hip replacement surgery, and to reduce the risk of strokes and blood clots in people with atrial fibrillation not caused by a heart valve problem.

ACS is poorly served by existing drugs and analysts have suggested that approval in this indication could add $1bn to Xarelto's potential market size.

Contributing to the panel's reluctance to endorse Xarelto in ACS could be the chequered history of other drugs in the same class in this indication. Pfizer's Eliquis (apixaban) and Astellas' darexaban both failed in ACS, although in those cases the primary problem was safety.

24th May 2012

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