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 acute coronary syndrome (ACS) patients, the firms will seek FDA approval for the blood thinner for that indication this year, J&J spokesman Ernie Knewitz told MM&M.  An FDA nod for ACS would expand Xarelto’s  Factor Xa market.

Xarelto (rivaroxaban) met a primary efficacy endpoint in the Phase III trial, albeit with higher bleeding rates. Full trial results are to be presented at a future scientific meeting. “We’re looking to find an appropriate scientific venue to present the data,” Knewitz said.

The oral anticoagulant is now on the market for clot prevention in some surgery patients, and regulators are considering the drug for stroke prevention in atrial fibrillation (SPAF). An FDA panel voted to okay it for SPAF and is due to issue a final decision by November 5.

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. According to a Bernstein Research note cited by Dow Jones, the ACS market is potentially worth $3 billion.

An ACS nod for Xarelto could affect several companies. Bernstein’s Tim Anderson suggested a “halo effect” for other indications could lead prescribers and payers to “unintentionally think more favorably about Xarelto in SPAF.” That may upset the market dynamic for Xarelto vs. Eliquis and vs. Pradaxa, both with strong AFib data.

A Xarelto success in ACS could create a new competitor vs. Eli Lilly’s Effient and AstraZeneca’s Brilinta anti-platelet therapies, Anderson noted. If an aspirin/Xarelto combination, with or without Plavix, has a substantial benefit in ACS, “Xarelto could become a direct competitor to Brilinta,” he wrote.

ISI analyst Mark Schoenebaum said ACS success bears little impact on Xarelto’s pending SPAF ruling, due 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 figure out the clinical relevance.

From the November 01, 2011 Issue of MM+M - Medical Marketing and Media