J&J's blockbuster hopeful Xarelto bounces back with AdComm backing

The blood thinner Xarelto came through an FDA advisory committee meeting looking better than some had expected. The AdComm backed approval of the potential blockbuster for preventing stokes in patients with atrial fibrillation by a margin of 9-2 yesterday. The vote came after an FDA staff review earlier this week advised against approval for this use.

Now Johnson & Johnson ($JNJ) and Bayer ($BAYN) have some momentum. The FDA often follows the recommendations of the panels and is expected to decide on the approval by November. Looking ahead to the potential marketing of the drug for the Afib group, the drugmakers can be happy about the panel's desire to see alternatives to the old standby warfarin. Although warfarin is much cheaper than Xarelto (rivaroxaban) and the new crop of blood thinners, it also carries side effects and requires diligent monitoring of patients who take it.

Based on the FDA staff's lambasting of Xarelto this week, it initially appeared the drug faced an uphill battle with the AdComm. The agency staff review concluded patients might even be at greater risk of bleeding or stroke on the new drug than if they were on carefully administered warfarin. However, the panel's vote shows just how differently two camps can view the same evidence. And analysts who were predicting doomsday for Xarelto after the staff review might have to change their lowered expectations for the drug's success in the huge Afib market.

Yet the jury might be out on whether Xarelto provides enough of a benefit for some patients compared with warfarin to justify its higher price tag. Furthermore, the drug faces competition from Boehringer Ingelheim's recently approved Pradaxa and a potential rival in Pfizer's ($PFE) and Bristol-Myers Squibb's ($BMY) Eliquis (apixaban), which has produced impressive safety and efficacy data in trials.

Xarelto "is a step in the right direction, but the benefit, even among thousands of patients, is tiny," cardiologist Eric Topol, chief academic officer at Scripps Health, told the Wall Street Journal. "Can we afford this now? We're committing people for the rest of their lives for maybe $5, $6 or $7 a day."

- read the WSJ report
- see the New York Times blog piece

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