USA-based FibroGen's (Nasdaq: FGEN) shares have dropped by more than a third after a scientific panel of the US Food and Drug Administration voted against approval of roxadustat.
The committee voted 13 to one against roxadustat as a treatment for anemia in chronic kidney disease (CKD) in non-dialysis dependent adults, and 12 to two against approval as a treatment for anemia in CKD in dialysis-dependent adults.
In the meeting, panellists discussed the safety profile of the medicine, and concluded that more safety data should be generated before approval is granted.
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 2024 | Headless Content Management with Blaze