FDA puts Xarelto's ACS indication on fast track

The FDA has opened up the fast lane for Bayer and Johnson & Johnson's ($JNJ) new blood thinner Xarelto. The drug will get priority review for a third indication: treating patients with acute coronary syndrome. If approved, the indication could be big for Xarelto, putting it ahead of its new-generation rivals for that patient group.

Already approved in the U.S. to cut the risk of stroke in patients with atrial fibrillation and to prevent blood clots in patients who'd had joint-replacement surgery, Xarelto had been considered something of an also-ran to Pfizer ($PFE) and Bristol-Myers Squibb's ($BMY) therapy Eliquis. As positive data mounted, analysts were crowning that drug as the putative leader of the warfarin-rival pack.

But lo and behold, Bayer unveiled data showing that Xarelto cut the risk of heart attacks, strokes and cardiovascular death in ACS patients. Indeed, the risk of death fell more than 30% with Xarelto use, when the drug was added to the standard clot-busting regimen. That's an outcome that Pfizer and BMS failed to achieve when Eliquis was studied in a similar patient population.

The ACS indication isn't expected to be as promising as the stroke-prevention use, analysts have said. But given that ACS sales weren't figured into Xarelto's forecasts before the study results made their debut, an approval would only boost those numbers. There's one potential drawback: Xarelto patients in the ACS study did have an increased risk of bleeding, always a fear with anti-clotting drugs. But the FDA may well decide the outcomes are worth that risk.

- read the Reuters news