Johnson & Johnson had big hopes for its anticoagulant Xarelto (rivaroxaban).

Expanding its use within the lucrative blood thinner market would put it in the big leagues, joining the ranks of Coumadin and Pradaxa. But the Food and Drug Administration (FDA) has once again given J&J less than favorable reports on its new drug.

Courtesy of the CDC
Xarelto increases the risk of bleeding.

An FDA expert panel denied Johnson & Johnson’s request to expand the use of Xarelto to treat blood clots in patients with acute coronary artery disease (CAD). The panel questioned whether Xarelto could actually reduce the risk of heart issues among those patients who’ve already had a heart attack.

The drug is already approved to prevent blood clots in the legs, pulmonary embolisms and to address an irregular heart beat (non-valvular atrial fibrillation) in hopes of reducing the risk of heart attack or stroke. It is prescribed for patients who just had hip or knee surgery.

J&J wanted to expand the uses for Xarelto to include acute coronary syndrome (ACS) which occurs when blood flow is reduced to the heart causing heart attack or chest pains. As a compromise, the company suggested Xarelto be used in the 90 days following a heart attack to prevent another.

Two days earlier an FDA review looking at company data decided there was not enough information forthcoming from J&J to decide if the risks of bleeding were worth the benefits. Unlike warfarin (Coumadin) there is no antidote to stop the bleeding with Xarelto.

The Food and Drug Administration has not been in agreement with much of what J&J has provided so far on the drug. Originally, the company applied for expanded approval in 2011 – but the FDA denied the application. Then a second application was also denied. J&J came back with a new application suggesting the drug be used for the shortened period of time.

Besides the increased risk of bleeding, there are two competitors on the market currently approved to treat ACS – Effient (Lilly) and Brilinta (AstraZeneca) – so there is not an urgent need to consider adding another drug to the market.

A Wells Fargo analyst tells the Cheat Sheet that sales of Xarelto topped $703 million last year, which doesn’t exactly give the drug blockbuster status.

The Jackson Sun quotes cardiologist Dr. Steven Nissen, an FDA panelist and chairman of cardiology at the Cleveland Clinic, “Everybody, even the sponsor, would agree that this drug increases the risk of bleeding…And in that context the quality of the data becomes increasingly important.”

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