EMA offers reassurance after Xarelto trial fault

9 February 2016

German pharma major Bayer's (BAYN: DE) stroke-prevention drug Xarelto (rivaroxaban) can still be used safely, even though a faulty device was used in a study supporting its approval, the European Medicines Agency (EMA) has announced.

The EMA said the defective international normalized ratio (INR) device did not affect the main results of the study.

It found the overall safety or benefit-risk balance of the drug in stroke-prevention in patients with atrial fibrillation was not affected and said: "Xarelto can continue to be used as before, in line with the current prescribing information."

This article is accessible to registered users, to continue reading please register for free. A free trial will give you access to exclusive features, interviews, round-ups and commentary from the sharpest minds in the pharmaceutical and biotechnology space for a week. If you are already a registered user please login. If your trial has come to an end, you can subscribe here.

Try before you buy

Free

7 day trial access

Take a Free Trial

All the news that moves the needle in pharma and biotech
Exclusive features, podcasts, interviews, data analyses and commentary from our global network of life sciences reporters.
Receive The Pharma Letter daily news bulletin, free forever.

Become a subscriber

£820

Or £77 per month

Subscribe Now

Unfettered access to industry-leading news, commentary and analysis in pharma and biotech.
Updates from clinical trials, conferences, M&A, licensing, financing, regulation, patents & legal, executive appointments, commercial strategy and financial results.
Daily roundup of key events in pharma and biotech.
Monthly in-depth briefings on Boardroom appointments and M&A news.
Choose from a cost-effective annual package or a flexible monthly subscription

The Pharma Letter is an extremely useful and valuable Life Sciences service that brings together a daily update on performance people and products. It’s part of the key information for keeping me informed

Chairman, Sanofi Aventis UK