FDA staff backs J&J's Xarelto for heart condition

As Johnson & Johnson ($JNJ) builds the blockbuster pedigree of Xarelto, an FDA reviewer has given the thumbs-up to the new clot-busting drug as a treatment for the heart problem known as acute coronary syndrome. The staffers' recommendation of approval comes ahead of Wednesday's advisory committee meeting on the expanded use of J&J and Bayer's Xarelto in ACS patients.

While Xarelto was associated with steep rises in bleeding risks, a 2.5-milligram dose of the drug cut down heart attacks and strokes 15% compared with placebo in patients studied, Bloomberg reported. On Wednesday, the committee of non-agency advisers to the FDA will weigh in on whether those risks and benefits merit the new approval for the drug, which has already gotten the green light to stymie strokes in patients with atrial fibrillation and in patients who undergo knee and hip surgeries.

Yet Reuters chose to bore into how the FDA staff review pointed to a lack of data to support Xarelto's ability to reduce heart attacks and strokes, indicating that this raises questions about the drug in ACS patients.

Bleeding risks are common among blood-thinning drugs, and analysts don't expect this safety issue to thwart approval of Xarelto to combat ACS, which causes clotting that impedes blood flow to the heart. With the ACS indication, Xarelto could eventually bring in an additional $400 million to $700 million annually, according to analysts at Cowen. And the expanded use could give the therapy a new leg up among next-generation blood-thinners such as Boehringer Ingelheim's Praxada and Pfizer ($PFE) and Bristol-Myers Squibb's ($BMY) Eliquis.

"Our clinical consultants view Xarelto's reward/risk profile in ACS patients as positive, and predict an approval recommendation," analysts at Cowen wrote in a note to investors on Friday. "They also believe that Xarelto's mortality benefit in ACS is an important differentiation relative to Pradaxa and warfarin, and should bolster Xarelto's adoption across the atrial fibrillation patient population."

- read Bloomberg's story
- see Dow Jones Newswire's report
- and Reuters' take

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