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Johnson & Johnson's Xarelto Should Be Given to More Patients, FDA Staff Says


J&J wants to sell its blood-thinning drug to help prevent heart attack and stroke in patients with a medical history. Competition from Pfizer and Bristol-Myers may be only months away.

MINYANVILLE ORIGINAL The competition for a better drug to treat blood clots involves some of the biggest names in pharmaceuticals and is about to get more interesting as some key event dates approach.

Johnson & Johnson (JNJ) received a bit of good news Monday morning when a staff reviewer for the Food and Drug Administration said the company's blood-thinning drug should be approved to help prevent heart attack and strokes in patients with a medical history of chest pains or heart attacks. Xarelto was first approved last July to help prevent blood clots and resulting problems in people who have knee or hip replacements. In November, the drug was approved for the additional use of stroke prevention for people with abnormal heart rhythms.

The recommendation Monday came in advance of a meeting of government advisers on Wednesday who will consider the safety and effectiveness of Xarelto for heart attack and stroke risk. That panel will make a recommendation to the FDA, which is scheduled to make a decision by June 29.

"I recommend approval of Xarelto to reduce the risk of cardiovascular events" in patients at risk, FDA staff reviewer Karen A. Hicks says in documents prepared for Wednesday's meeting. The drug appeared to be effective in J&J studies, she says.

Shares of J&J rose less than 1% to $63.52. The stock is down 3% this year.

Expanding Xarelto's patient base would certainly be a positive for the drug. However, Pfizer (PFE) and partner Bristol-Myers Squibb (BMY) await word from the FDA on their own blood thinner right around the same time as J&J's decision date. The FDA is scheduled to rule by June 28 on Pfizer and Bristol-Myers' drug Eliquis for preventing strokes in people with a history of irregular heartbeat. Eliquis is approved in Europe.

The big German drug maker Boehringer Ingelheim's anti-clotting drug Pradaxa was approved in the US in late 2010. J&J is partnered with another German company, Bayer, which sells Xarelto in Europe.

These big companies are chasing a multi-billion-dollar opportunity to sell a treatment that is better than the longtime standard of care warfarin. Used in patients more than half a century, warfarin can produce serious side effects, including life-threatening bleeding. (The drug was once used as a rat poison.)

Les Funtleyder, a portfolio manager at Miller Tabak, says he believes Xarelto will be approved for the additional use but he sees a real potential competitive risk to J&J if Eliquis is approved. Miller Tabak holds shares of J&J.

Eliquis "seems to have a better risk benefit profile and may be used ahead of Xarelto," Funtleyder says. (That's assuming Eliquis is approved.)

Twitter: @brettchase

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