An expert panel convened by the US Food and Drug Administration has recommended Bayer's Xarelto (rivaroxaban) for approval. Shares in the German drug major rose as much as 9% in morning trading after the news on March 20.
Developed with US health major Johnson & Johnson, the once-daily anticoagulant was given the go-ahead as a treatment for the prevention of deep vein thrombosis and pulmonary embolism in patients undergoing hip or knee replacement surgery.
The members of an advisory committee to the FDA voted 15 to two that "available clinical data demonstrated a favorable risk-benefit profile." The recommendation reverses negative sentiment a few days before the meeting, which saw shares in Bayer fall 10% to 32.69 euros on March 17, after documents were posted on the FDA's web site stating that Xarelto carries a high risk of internal bleeding.
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.
Login to your accountTry before you buy
7 day trial access
Become a subscriber
Or £77 per month
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
Copyright © The Pharma Letter 2025 | Headless Content Management with Blaze