FDA rejects Xarelto’s bid to treat acute coronary syndrome
The Food and Drug Administration (FDA) rejected expanding the indication for the new blood thinner Xarelto to prevent heart attacks and strokes in patients with a common heart condition known as acute coronary syndrome. The agency said there was too much missing data from 1,000 patients who withdrew from a late-stage trial on the medication.
Xarelto, made by Johnson & Johnson and Bayer, was approved by the FDA in July 2011 for the prevention of blood clots in patients undergoing knee and hip replacement surgeries. In November, the agency expanded the indication to include stroke prevention in patients with an irregular heat rhythm known as atrial fibrillation.
The drug makers had hoped the anticoagulant could also be used in acute coronary syndrome patients, but couldn’t provide data that showed whether the patients who dropped out of the trial were even still alive. The Xarelto study began with 15,526 patients, but nearly 1,300 dropped out during the final phase. Researchers were able to confirm 177 of the patients were still alive, but the fate of the remaining 1,100 or so patients is a mystery.
Xarelto, and recent predecessor Pradaxa, made by Boehringer Ingelheim, are in a new class of blood thinners designed to go head-to-head with warfarin, which has been on the market for 60 years. Warfarin requires regular monitoring and blood tests because using it puts patients at increased risk for internal bleeding.
Pradaxa and Xarelto were considered safer alternatives that didn’t require monitoring. However, reports of bleeding events and deaths associated with Pradaxa have raised concerns over the safety of the blood thinner. The Institute for Safe Medication Practices recently estimated that the FDA had received 542 reports of death with Pradaxa in 2011. Warfarin, in comparison, was associated with only 72 deaths that same year. Data for Xarelto was not available since the drug has only been available for a few months.
Johnson & Johnson says it is confident in Xarelto’s benefit to acute coronary syndrome patients and will continue to work with the FDA to fully address questions with the data.