European regulator says anticoagulant is safe, despite question marks over its pivotal trial

european-medicines-agency-ema

The European Medicines Agency (EMA) has reiterated the overall safety of rivaroxaban (Xarelto), an anticoagulant, despite a defect in a device used in a pivotal study behind the drug’s marketing approval in the European Union and the United States. 

An analysis of the ROCKET data found that any incorrect measurements recorded by the international normalised ratio (INR) device would have had a “marginal” effect on the overall trial results, according to a review by the EMA’s Committee for Medicinal Products for Human Use (CHMP). 

The CHMP concluded that the benefit-risk ratio of rivaroxaban — an oral, direct activated factor X (Xa) inhibitor — in patients with non-valvular atrial fibrillation remained unchanged which means the product can continue to be used according to current prescribing guidelines. 

The results of the EMA analysis were made public on 5 February 2016, two days after the 
The BMJ
published the results of its investigation, which questioned the validity of the ROCKET data because it relied on an INR device that had been recalled in December 2014 after giving falsely low test results. 

The same day as The BMJ investigation was published, the researchers behind the original 2011 ROCKET study writing in the
New England Journal of Medicine
produced data to confirm that the “possible malfunction” of the INR device “did not have any significant clinical effect on the primary efficacy and safety outcomes in the trial”.

Last updated
Citation
The Pharmaceutical Journal, February 2016;Online:DOI:10.1211/PJ.2016.20200706