US Bioscience has amended its New Drug Application for Ethyol (amifostine) in response to questions raised by the US Food and Drug Administration in December of last year.
The amendment includes further analysis and an update of the completed pivotal trial in ovarian cancer. The company, which is seeking an approval for Ethyol as a chemoprotective agent, was informed by the FDA that it needed more definitive survival data. USB said that the trial results released in May showed that the agent does not adversely affect survival.
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