Bayer, J&J's Xarelto wins key FDA nod, with warning

Bayer and Johnson & Johnson ($JNJ) snagged the crucial stroke-prevention indication for their new clot-fighter Xarelto. The FDA approval isn't without its caveats, however. FDA may have granted the new use despite objections from staffers, who had questioned the usefulness of a key study, but the agency didn't give Xarelto a snag-free label.

J&J, which markets the drug in the U.S., won't be able to tour Xarelto as superior to the standard therapy, warfarin. And Xarelto will carry a black-box warning against sudden discontinuation of therapy, because atrial fibrillation patients who stopped taking the drug in clinical trials experienced a higher rate of strokes, the agency said.

Xarelto won a postive opinion for stroke prevention from European regulators earlier this year, so it may soon be approved for that use in AF patients on both sides of the Atlantic. Previous indications for clot prevention in surgery patients aren't nearly so important as the stroke-prevention use, because it covers long-term therapy in a large population of potential patients. Bayer has forecast $2.5 billion in sales, while J&J expects up to $800 million by 2015.

In the AF market, Xarelto comes up against Boehringer Ingelheim's Pradaxa, which has the first-to-market advantage, but also faces some safety questions of its own. Last week, it agreed with European regulators to call for kidney-function testing in high-risk patients, to make sure Pradaxa's active ingredient is cleared from the blood stream at the correct rate, to help avoid potentially dangerous bleeding. Xarelto will eventually have to contend with Bristol-Myers Squibb and Pfizer's entrant Eliquis, which has the strongest efficacy and safety data of any of these new warfarin-alternative meds.

But Xarelto has one potentially important edge: A recent trial found that the drug helped prevent heart attacks, strokes and death in patients with acute coronary syndrome. Patients using the drug did experience an increased risk of bleeding, but presumably not as much risk as patients in an Eliquis trial that was stopped because of excess bleeding. Bayer and J&J said they intend to seek regulatory approval for an ACS indication by year's end.

- see the release from FDA
- read the Reuters story
- get more from The Wall Street Journal
- check out the InPharm coverage