Will Xarelto become the first Factor Xa inhibitor with an indication for use in patients who have had a heart attack or similar symptoms?
Based on a preview of data from a clinical trial testing the Johnson & Johnson/Bayer drug in patients with acute coronary syndrome (ACS), the firms will seek FDA approval for the blood thinner for that indication by year's end, J&J spokesman Ernie Knewitz told MM&M.
Xarelto (rivaroxaban) met a primary efficacy endpoint in the Phase III trial, albeit with increased bleeding rates. Full results of the trial, known as Atlas, are to be presented at a scientific meeting in the future.
“We're looking to find an appropriate scientific venue to present the data and should have an update on that relatively soon," Knewitz said. J&J, which holds the new drug application in the US, is considering the American Heart Association this November, among a handful of other major cardiology congresses.
The oral anticoagulant is already on the market for clot prevention in some surgery patients, and regulators are considering the drug for preventing strokes in atrial fibrillation (SPAF). An FDA panel voted to okay it for SPAF and is due to issue a final decision by November 5th.
Earning an FDA nod for ACS would broaden the Factor Xa market. A similar trial of Pfizer/Bristol-Myers Squibb's Eliquis (apixaban) was stopped this summer because of increased bleeding, and Boehringer Ingelheim's Pradaxa (a direct thrombin inhibitor, not a factor Xa) has not been studied in that indication.
Meeting the primary efficacy endpoint is an “upside surprise” for Xarelto and may open up a “blockbuster market opportunity,” wrote Leerink Swann's Seamus Fernandez in an investor note. Indeed, the ACS market is potentially worth $3 billion, according to a Bernstein Research note cited by Dow Jones.
If Xarelto gets an ACS indication, several other companies could be affected. Bernstein's Tim Anderson noted that ACS could have a positive “halo effect” for other indications, leading prescribers and payers to “unintentionally think more favorably about Xarelto in SPAF.”
That could upset the competitive dynamic for Xarelto vs. Eliquis and vs. Pradaxa, both of which have shown very strong AFib data. In an earlier note, Fernandez had written that he wouldn't be surprised if regulators give Xarelto a second- or third-line approval in AFib.
If Xarelto succeeds in ACS, it could also bring forward a new competitor vs. Eli Lilly's Effient and AstraZeneca's Brilinta anti-platelet therapies, Anderson pointed out. If an aspirin/ Xarelto combination, with or without Plavix, turns out to have a substantial benefit in ACS, “Xarelto could become a direct competitor to Brilinta and undermine its market potential in ACS,” he wrote.
But ISI analyst Mark Schoenebaum said success in ACS bears little impact on Xarelto's pending ruling in SPAF, owing to differences between the indications and to Xarelto's competitors. Like the other analysts, he's looking to the full data set to discern details around hazard ratios and to figure out the clinical relevance.