Johnson & Johnson’s blood thinning drug gets a bad review from the US Food and Drug Administration staff.
In a report released on Tuesday, an FDA staff suggested against the drug candidate, Xarelto, intended for stroke prevention in patients with a common irregular heart rhythm. According to the report, data from a late-stage study does not establish the safety of Xarelto, or its superiority and efficacy over the commonly used warfarin.
Xarelto received approval in July. The drug is intended to treat patients getting knee and hip replacements to decrease the risk of deadly blood clots.
The drug was jointly developed by Bayer Healthcare of Germany in partnership with Johnson & Johnson.
Subsequently, a panel apart from the FDA advisory is due to review the drug research on Thursday.