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FDA Accepts Supplemental Biologics License Applications for BIMZELX® (bimekizumab-bkzx) for Moderate to Severe Hidradenitis Suppurativa and Additional

Application in moderate to severe hidradenitis suppurativa based on results from two Phase 3 studies where bimekizumab-bkzx showed clinically meaningful improvements vs. placebo at Week 16 which were sustained to Week 48Application for the additional bimekizumab-bkzx 2mL device presentations aims to provide more opt. ....

Emmanuel Caeymaex , Drug Administration , European Union , European Union Economic Area , Immunology Solutions , Biologics License Application , Executive Vice President , Important Safety Information , Herpes Simplex Infections , Important Safety , Product Characteristics , European Economic ,