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FDA rejects J&J/Bayer's Xarelto in ACS

Missing patient records mean drug misses out on potential lucrative market

Johnson & Johnson (J&J) and Bayer have failed in a bid expand the indications for their anticoagulant Xarelto in the US to include the treatment of patients with acute coronary syndrome (ACS).

The US FDA sent the two companies a complete response letter turning down the marketing application for Xarelto (rivaroxaban) in combination with standard antiplatelet therapy for the reduction of cardiovascular death, myocardial infarction or stroke in patients with ACS.

The decision was not a surprise, given that an FDA advisory committee voted against the use of Xarelto in this setting last month. This was based on concerns about incomplete records on around 12 per cent of the patients enrolled in J&J and Bayer's ATLAS ACS 2 TIMI 51 study, which formed the basis of the marketing application.

A total of 1,294 subjects discontinued the trial prematurely, and the investigators were only able to contact 183, of whom 177 were alive at follow-up. Because of the missing patients, the panel concluded that the data on mortality were not reliable.

In a statement, the two companies said they are evaluating the letter and will respond to the agency's questions in due course, although analysts have suggested the programme may be delayed by up to a year.

"We are confident of the safety and efficacy of rivaroxaban in this indication and will work closely with our development partner … to address the questions set forth by the FDA," said Dr Kemal Malik, Bayer's head of global development.

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.

Approval in ACS would have allowed Xarelto to tap into a new market worth an estimated $1bn a year.

Xarelto is not the first new anticoagulant to fail in this indication, however; Bristol-Myers Squibb/Pfizer's Eliquis (apixaban) and Astellas' darexaban were both prevented from securing approval in ACS because of bleeding complications.

22nd June 2012

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