Looks like you’re on the UK site. Choose another location to see content specific to your location

Home Industry News Bayer’s Xarelto receives EU backing for positive risk-benefit profile

Bayer’s Xarelto receives EU backing for positive risk-benefit profile

10th February 2016

Bayer has announced that the European Medicines Agency has confirmed the positive risk-benefit profile of its novel oral anticoagulant Xarelto in stroke prevention among patients with atrial fibrillation. 

The regulator's Committee for Medicinal Products for Human Use investigated the safety and efficacy of the drug after it was found that a key monitoring device used in the ROCKET AF study of Xarelto had potentially malfunctioned.

Concerns were raised that this could have skewed the findings of the study. However, Bayer and its development partner Janssen have since undertaken a thorough analysis of the data, with the ROCKET AF executive committee also re-examining the findings.

It has since been decided that the defective device had only a marginal impact on the study results, meaning it should not affect conclusions on the overall safety or benefit-risk balance of Xarelto, which can now continue to be used as before.

Dr Michael Devoy, head of medical affairs and pharmacovigilance at Bayer's pharmaceuticals division and the company's chief medical officer, said: "The re-analyses are reassuring and will provide physicians with additional confidence to prescribe Xarelto for their patients with atrial fibrillation at risk of stroke."

Xarelto is the most broadly indicated non-vitamin K antagonist oral anticoagulant and is currently approved in seven different indications.ADNFCR-8000103-ID-801812248-ADNFCR

We currently have 9 jobs available in Pharmacy industry, find your perfect one now.

Stay informed

Receive the latest industry news, Tips
and straight to your inbox.