UCB achieves important regulatory milestone for bimekizumab

UCB

22 September 2020 - The U.S. FDA and EMA have accepted marketing application submissions for bimekizumab for the treatment of adults with moderate to severe plaque psoriasis.

UCB today announced that the FDA and EMA have accepted the biologics license application and marketing authorisation application, respectively, for bimekizumab for the treatment of adults with moderate to severe plaque psoriasis.

The marketing application submissions for bimekizumab are based on data from a global Phase 3 clinical development program in psoriasis.

Read UCB press release

Michael Wonder

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Michael Wonder

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Medicine , Europe , US , Dossier