March 6, 2021

Prescriptions Blog: F.D.A. Deals Blow to a New Anticoagulant

The Food and Drug Administration staff on Tuesday recommended against approving the new anticoagulant drug Xarelto to prevent strokes in people with a common heart arrhythmia.

The setback for the drug, contained in an F.D.A. briefing document released in advance of an advisory committee meeting on Thursday, surprised some doctors and analysts who had expected easy approval for Xarelto.

The drug is made by Johnson Johnson and Bayer. It was previously approved to prevent clots after hip and knee replacement surgeries. But the overall market for atrial fibrillation patients is much larger, estimated at up to $10 billion a year as part of a new class of drugs to replace warfarin, the 50-year-old blood thinner commonly used to prevent clots and strokes.

In rejecting Xarelto for atrial fibrillation, the F.D.A. reviewers said the crucial clinical trial did not prove it was as good as warfarin. They said the industry-financed trial was flawed because warfarin was not “used skillfully” in it, with a lower overall measurement of its “time in therapeutic range” compared with other recent trials.

“If the underlying goal of protecting public health is to be advanced, the logical course is to reject the new therapy because it has not been convincingly demonstrated to be as effective as approved therapy,” the F.D.A. staff wrote.

JJ and Bayer are expected to defend the study at the F.D.A. scientific advisory committee on Thursday. The F.D.A. will make its final decision some time after that.

Xarelto had been expected to be one of a handful of new drugs for atrial fibrillation that their makers hoped would avoid the drawbacks of warfarin, like interactions with other drugs and foods, requiring careful and frequent monitoring of the level of warfarin in the blood. The new drugs are also expected to be much more expensive than generic warfarin.

Pradaxa, from the German drug maker Boehringer Ingelheim, was approved last fall as the first of these new drugs. Eliquis, from Bristol-Myers Squibb and Pfizer, is expected to be submitted to the F.D.A. this fall. Its recently finished clinical trial showed the best results of them all with reductions to strokes, major bleeding and overall mortality.

One of Xarelto’s hoped-for advantages over those other two drugs was that it could be taken once a day. The others are to be taken twice a day. But F.D.A. reviewers said studies suggest all of the new types of drugs might be best taken twice a day.

The reviewers recommended against approving Xarelto for atrial fibrillation or approving it only as second or third line therapy.

A Bernstein Research analyst note on Tuesday said the F.D.A. review was more negative than expected. Xarelto had been a major pipeline drug for Johnson and Johnson, the note said, and a potential big seller for Bayer.

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