Hopes for what would be the first new antifungal based on a novel mechanism for decades have been dealt a blow by the US Food and Drug Administration.
Manchester, UK-based antifungal specialist F2G has received a Complete Response Letter (CRL) from the US medicines regulator for its rare fungal mold candidate olorofim.
The US FDA has asked for additional data and analyses which the company said would require “time and resources that extend beyond the current review period.”
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