FDA Review Suggests Skepticism of Johnson & Johnson Drug’s Efficacy


An FDA review of Johnson & Johnson‘s (NYSE:JNJ) anticoagulant drug, Xarelto, is markedly less-than-favorable. The report, which was released Tuesday, is skeptical as to whether the company’s data proves that the drug could find a new application in reducing the risk of further heart problems in patients who have already had a heart attack, Reuters reports. The FDA review comes two days before outside experts are scheduled to meet to discuss the drug’s new, proposed application and decided whether it should be approved.

Xarelto is already used as a preventative medicine for a number of different conditions, including the prevention of pulmonary deep vein thrombosis, pulmonary embolisms, and also to help reduce the risk of stroke and blood clots in patients with an irregular heart beat that is not caused by heart problems.

The company is hoping that the drug will also be approved for use as a preventative medicine for patients with acute coronary syndrome (or, ACS), a term that covers any condition that brings about sudden reduced blood flow to the heart, including heart attacks and chest pains, and claims that Xarelto, which is also known as rivaroxaban, should be used in the first 90 days after suffering a heart attack.

The current meeting comes after several prior rejections by the FDA for the same application of the drug; Johnson & Johnson originally applied for approval in 2011, and was denied. The company then provided additional information, as requested, and was denied again. The company then appealed the decision, and was denied yet again, at which point the FDA suggested that limiting the duration of the drug to one month might be the most effective path towards approval; Johnson & Johnson then filed a new application with a treatment duration for the drug set to 90 days.

Analysts are not optimistic, and the FDA’s review suggests skepticism on the part of the agency as well. ”It’s unclear how to choose the metric for determining when the benefit of rivaroxaban is greatest,” the review found. “Not only does the effect rivaroxaban not appear to be greater earlier, but an effect in the first 90 days or so is not apparent at all,” the FDA review said, per Reuters.

Larry Biegelsen, an analyst at Wells Fargo, says he wouldn’t get his hopes up. “Based on our review of this material, we continue to have low expectation of approval.” Biegelsen continued that, “We can expect the ACS potential to be modest, even if approved.” That being said, the analyst says he does expect that sales of the drug will rise to $1.2 billion in 2015 from approximately $703 million in 2013.