Posted by Michael Wonder on 22 Nov 2022
UCB submits response to FDA complete response letter for bimekizumab
22 November 2022 - UCB today announced that it has resubmitted the biologics license application to the US FDA for bimekizumab for the treatment of adults with moderate to severe plaque psoriasis.
The resubmission follows the receipt of a complete response letter from the FDA in May 2022 which stated that certain pre-license inspection observations must be resolved before the application may be approved.
