Xarelto could be one step closer to justifying the aggressive sales projections tossed out by Bayer CEO Marijn Dekkers. The anticoagulant won a thumbs-up from FDA's clinical reviewer, ahead of Wednesday's advisory panel meeting, where FDA experts will weigh a lucrative new indication. Agency staff raised some questions about missing data, however, setting the stage for a "heated debate," Reuters reports.
That use--to prevent heart attacks and strokes in patients with acute coronary syndrome--would considerably broaden Xarelto's U.S. market. Sold by Johnson & Johnson ($JNJ) in the U.S., Xarelto is now approved to prevent strokes in patients with atrial fibrillation and reduce the risk of blood clots in certain surgery patients.
The AF indication is crowded, however, and is expected to grow more crowded still. There, Xarelto faces the old-standard drug warfarin, plus one of the new-generation alternatives, Boehringer Ingelheim's Pradaxa. Pfizer ($PFE) and Bristol-Myers Squibb's ($BMY) entrant Eliquis, which some consider the likely market leader in AF patients, awaits an FDA decision next month.
By contrast, Xarelto would be the sole warfarin alternative approved for ACS patients. It would compete with AstraZeneca's ($AZN) Brilinta and Eli Lilly's ($LLY) Effient, and market-watchers think it could dominate. Xarelto "will probably be a market leader," Miller Tabak's Les Funtleyder told Bloomberg. Both he and Barclays analyst Tony Butler think FDA will give Xarelto the new indication, the news service reports.
Xarelto does come with some risks; compared with placebo, it doubled the risk of fatal bleeding and tripled the risk of major bleeding and bleeding events. So, one question up for the advisory panel: whether to put those risks in a black-box warning.
Another is the one raised by FDA medical team leader Thomas Marciniak, who pointed out three deaths that went uncounted. Those three "may be the tip of the iceberg regarding problems with missing data," Marciniak wrote (as quoted by Reuters). Still, FDA reviewer Karen Hicks says it's worth the hazards: "The benefit-risk ratio for Xarelto appears to be favorable," Hicks wrote, saying that she recommended it to reduce "the risk of cardiovascular events."
Wells Fargo analyst Larry Biegelsen said he believes the advisory committee will vote in favor of the new use, Reuters reports. As Biegelsen wrote in a note to investors, "We expect a very heated debate on (Wednesday), however, we continue to expect a positive outcome."