FDAnews Drug Daily Bulletin
Pharmaceuticals / Postmarket Safety

Real-World Data Confirms Safety of Xarelto

Sept. 9, 2015
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Real-world data from two atrial fibrillation studies confirm the safety profile of Janssen and Bayer’s Xarelto.

The companies designed the studies in agreement with the FDA and European Medicines Agency as part of postmarketing requirements to analyze and report major bleeding events with the stroke prevention drug. The results, based on more than 45,000 patients from 22 countries, found rates of major bleeding were low at 2.89 and 2.1 per 100 person-years, respectively.

The main U.S.-based PMSS trial is an ongoing five-year retrospective study with no comparator arm. The smaller Xanthus study also had no comparator arm and was conducted in Europe, Canada and Israel. Both studies had low instances of fatal bleeds, with 0.1 and 0.7 per 100 person-years, respectively, Janssen says.

PMSS study investigator W. Frank Peacock says the findings are consistent with the Phase 3 data used by regulatory authorities worldwide to approve the medicine.

Xarelto (rivaroxaban) has come under fire this year, with lawsuits claiming it caused uncontrollable internal bleeding. — Kellen Owings