November 23, 2022
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UCB resubmits biologics license application for bimekizumab for plaque psoriasis
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UCB has resubmitted its biologics license application to the FDA for bimekizumab for the treatment of adults with moderate to severe plaque psoriasis, according to a company press release.
The FDA called for the resubmission when it issued a complete response letter (CRL) in May for certain pre-license inspection observations to be resolved before the application was approved. The CRL was not due to the efficacy or safety of bimekizumab, according to the press release.
After the FDA determines whether the resubmission constitutes a complete response, UCB will be notified of the resubmitted biologics license application’s classification.
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