Regulators to probe Bayer’s Xarelto trial results
pharmafile | December 10, 2015 | News story | Medical Communications, Research and Development |
Bayer’s blockbuster anticoagulant Xarelto is under scrutiny from regulators in Europe and the US, as they try to determine whether a defective blood clotting test device affected the results of a clinical trial.
The study compared Xarelto (rivaroxaban) to standard treatment warfarin for preventing strokes in patients with in Patients with a recent acute coronary syndrome. The European Commission approved Xarelto for this indication based in part on this trial data in March 2013, but it has since come to light that an INR (international normalised ratio) device used to measure the speed of blood clotting may have provided misleadingly low results. The system was recalled in December 2014.
“Due to the defect it is now thought that the INR device may have impacted the clotting results in some patients in the warfarin group,” the EMA said.
During a press briefing yesterday, EMA chief executive Guido Rasi said the Agency would welcome an independent study to re-evaulate Xarelto’s efficacy and reaffirm confidence in the use of the medicine, He added that the matter was brought to his attention at the beginning of his second tenure in November.
The US FDA also said it was aware of the issue and is conducting a review of relevant data, working closely with Bayer.
The German company-which jointly develops and markets Xarelto with Johnson&Johnson- will be encouraged by a statement from the Duke University Clinical Research Institute, which carried out parts of the trial, in which it claimed additional analysis had determined the INR device did not affect the overall trial results.
“The findings from the (secondary) analysis are consistent with the results from the original trial and do not alter the conclusions,” the statement read.
In addition, analysts pointed to the minimal impact that one defective device of potentially hundreds used in the study was likely to have on results.
Xarelto is an important and growing stream of revenue to Bayer, which has already brought in sales of $1.6 billion in the first nine months of 2015- a 38% increase on the same period last year. It is currently the company’s best selling product.
Bayer says Xarelto has a 34% global market share. As part of a new generation of anticoagulants that require less frequent monitoring of patients, it competes with Bristol Myers-Squibb and Pfizer’s Eliquis, and Boehringer Ingelheims’ Pradaxa.
Joel Levy
